Practitioner Resources - PREMIUM, PRACTITIONER-ONLY PRODUCTS - Activated Probiotics
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Practitioner
FOR PROFESSIONAL REFERENCE ONLY
Resources
PREMIUM, PRACTITIONER-ONLY PRODUCTS
FOR PROFESSIONAL REFERENCE ONLY PREMIUM, PRACTITIONER-ONLY PRODUCTS 3
Summary Table
ACT IVAT ED PROB IOT ICS ® 7 B IOME PREN ATA L + TM P R O BI OT I C 47
The Gut Microbiome Clinical Summary
MicrobacTM Encapsulation Condition Management Guide
Fridge Free - Superior Shelf Stability Supporting Clinical Research
Billion Live Bacteria (BLB) - Strain Specificity Mechanism of Action
Clinical Research - Clinically Proven Products
B IOME A DVA N CED TM P R O BI OT I C 53
B IOME OST EO TM
PROB IOT IC 17 Clinical Summary
Clinical Summary Condition Management Guide
Condition Management Guide Supporting Clinical Research
Supporting Clinical Research Mechanism of Action
Mechanism of Action
B IOME DA ILY KIDS TM P R O BI OT I C 59
B IOME B REAT HE TM
PROB IOT IC 23 Clinical Summary
Clinical Summary Condition Management Guide
Condition Management Guide Supporting Clinical Research
Supporting Clinical Research Mechanism of Action
Mechanism of Action
B IOME DA ILY TM PROBI OT I C 65
B IOME L IF T TM
PROB IOT IC 29 Clinical Summary
Clinical Summary Condition Management Guide
Condition Management Guide Supporting Clinical Research
Supporting Clinical Research Mechanism of Action
Mechanism of Action
B IOME HER TM PROB IOT I C 71
B IOME IB S TM
PROB IOT IC 35 Clinical Summary
Clinical Summary Condition Management Guide
Condition Management Guide Supporting Clinical Research
Supporting Clinical Research Mechanism of Action
Mechanism of Action
B IOME ECZ EMATM PRO BI OT I C 77
B IOME IRON + TM
PROB IOT IC 41 Clinical Summary
Clinical Summary Condition Management Guide
Condition Management Guide Supporting Clinical Research
Supporting Clinical Research Mechanism of Action
Mechanism of Action
PRACT IT ION ER PORTA L & T R A I N I N G 83
FOR PROFESSIONAL REFERENCE ONLY
PREMIUM, PRACTITIONER-ONLY PRODUCTS 5
Activated Probiotics ®
The Gut
A PRIMER FOR HEALTH PROFESSIONALS THE BENEFITS OF PROBIOTICS
As medical science unravels the complex relationship between our gut microbiome and many aspects of our health and wellbeing,
Microbiome
there is an emerging role for the use of clinically researched probiotic products to tangibly improve our health. Probiotics are defined
as ‘live microorganisms that, when administered in adequate amounts, confer a health benefit on the host’.
The most well known benefits of probiotics relate to their ability to support the health of our digestive tract and immune system,
benefiting otherwise generally healthy people. However, certain strains of probiotic bacteria can target more specific aspects of our
Cutting-edge scientific research is helping us to understand how our gut health and wellbeing, including our mood, bone health, and nutrient absorption, and even help reduce the symptoms of complex
microbiome influences almost every aspect of our health. conditions, such as irritable bowel syndrome.
In order to impart the most health benefits to their host, probiotics need to meet three criteria:
1. Alive when ingested
Probiotics are living microorganisms that can be killed by adverse environmental conditions, including exposure to high
temperatures or moisture levels. This can occur if a probiotic product is not packaged or stored appropriately. Further,
probiotics need to be able to survive the harsh conditions in the upper gastrointestinal tract, including stomach acid, to arrive
alive in the large intestine, where they exert their beneficial effects.
2. Administered at an appropriate therapeutic dose
Each probiotic strain has an individual therapeutic dose, which depends on the particular probiotic strain and the condition
being treated. The most effective dose is determined by clinical trials, which consistently demonstrate that more is not
necessarily better. For example, clinical trials conducted in adults with irritable bowel syndrome have shown that a dose of
10 billion live bacteria of the probiotic Lactobacillus plantarum 299v can help relieve symptoms. While many products on the
market now contain over 100 billion bacteria per dose, these excessively high doses are not supported by scientific evidence
and may increase the risk of unwanted side effects, such as bloating and changes to the bowel habits.
3. Have a defined health benefit supported by research
The health benefits attributable to probiotics are strain-specific and need to be determined by clinical research. Even within the
same bacterial species, different strains can have very different biological activities in our gastrointestinal tract. Consider the
bacterial species Escherichia coli: the strain Escherichia coli O157:H7 causes severe food poisoning, while Escherichia coli Nissle
1918 is used as a probiotic.
THE HUMAN GUT MICROBIOME
From the inside of our gut to the surface of our skin, our bodies are host to thriving communities of microbial life, including bacteria, IS THERE ANYONE WHO SHOULDN’T TAKE PROBIOTICS?
viruses, archaea, and fungi. The most diverse and abundant community of microbes live in our gut, which is referred to as the Probiotics are contraindicated in patients who are immunocompromised or are very unwell. Before starting on any new medications
gut microbiome. We live in harmony with our gut microbes; in return for providing them with a food source and an environment or dietary supplements, patients should discuss their suitability with their usual doctor.
in which to live, they protect our body from invasion from pathogenic microorganisms, modulate our immune system, help us to
extract energy from our food, and produce a number of beneficial chemical compounds, such as short-chain fatty acids (SCFAs).
In recognition of their vital role in maintaining our health, some scientists believe the gut microbiome should be reclassified as an
additional organ of the body2.
REFERENCES
GUT DYSBIOSIS NEGATIVELY AFFECTS OUR HEALTH 1. Sender R, Fuchs S, Milo R. Revised Estimates for the Number of Human and Bacteria Cells in the Body. PLoS Biol. 2016;14(8):e1002533.
2. Amon P, Sanderson I. What is the microbiome? Arch Dis Child - Educ Pract. 2017 Oct 1;102(5):257–60.
While the type and abundance of microbes that live in the gut generally remains stable over time, external factors such as diet and
3. Mirsepasi-Lauridsen HC, Vrankx K, Engberg J, Friis-Møller A, Brynskov J, Nordgaard-Lassen I, et al. Disease-Specific Enteric Microbiome Dysbiosis in Inflammatory Bowel Disease. Front Med [Internet]. 2018 [cited 2019 Sep 6];5. Available from: https://www.frontiersin.org/
the use of certain medications can alter its composition. A disruption to our gut microbiome which negatively affects our health is articles/10.3389/fmed.2018.00304/full#B4
4. Arrieta M-C, Stiemsma LT, Dimitriu PA, Thorson L, Russell S, Yurist-Doutsch S, et al. Early infancy microbial and metabolic alterations affect risk of childhood asthma. Sci Transl Med. 2015 Sep 30;7(307):307ra152-307ra152.
referred to as ‘dysbiosis’. Just as Hippocrates proclaimed over 2000 years ago that all disease begins in the gut, it is now widely
5. Henao-Mejia J, Elinav E, Jin C-C, Hao L, Mehal WZ, Strowig T, et al. Inflammasome-mediated dysbiosis regulates progression of NAFLD and obesity. Nature. 2012 Feb 9;482(7384):179.
accepted by modern science that the influence of the gut microbiome extends far beyond our digestive tract6. Indeed, dysbiosis has 6. Louisa Lyon, ‘All disease begins in the gut’: was Hippocrates right?, Brain, Volume 141, Issue 3, March 2018, Page e20, https://doi.org/10.1093/brain/awy017
been implicated in a number of systemic diseases, including asthma4, obesity5 and countless others.
FOR PROFESSIONAL REFERENCE ONLY
PREMIUM, PRACTITIONER-ONLY PRODUCTS 7
Activated Probiotics ®
MicrobacTM
Encapsulation 1. Probiotics are
microencapsulated
Microbac encapsulation is an innovative probiotic delivery technology which
protects our probiotic bacteria by coating them with a thin layer of plant-
derived lipid. microbac TM
microbac TM
2. Probiotics are
protected from
stomach acid
3. Viable probiotics reach 4. Probiotics are
The effectiveness of any probiotic is dependent on surviving transit through the harsh environment of the upper gastrointestinal tract (GIT),
the large intestine activated
including the stomach and the duodenum, where bacteria are destroyed by stomach acid and protease enzymes.
As the upper gastrointestinal tract is less involved in the digestion of fats, the plant-derived lipid layer provided by Microbac resists
digestion, separates our probiotic bacteria from the harsh environment of the upper GIT and significantly increases survival rates.
Once it enters the small intestine, this layer is slowly digested by naturally occurring enzymes and bile salts, releasing unharmed probiotic
bacteria into the intended site of action: the large intestine.
Clinical trials, including one double-blind, randomised controlled trial, have shown that Microbac encapsulation allows 5x more bacteria to
survive transit through the upper gastrointestinal tract and colonise the large intestine, compared to traditional, uncoated strains1.
1. Del Piano M, Carmagnola S, Andorno S, Pagliarulo M, Tari R, Mogna L, et al. Evaluation of the intestinal colonization by microencapsulated probiotic bacteria in comparison with the same uncoated strains. J Clin Gastroenterol.
2010;44(SUPPL. 1):42–6.
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PREMIUM, PRACTITIONER-ONLY PRODUCTS 9
Activated Probiotics ®
Fridge Free -
Superior Shelf Stability
FREEZE-DRYING + MICROENCAPSULATION + BLISTER PACKAGING = SUPERIOR SHELF STABILITY
Freeze Drying
Our probiotics are freeze-dried, which is an industrial process employed to remove all moisture from the bacteria.
This puts them into a state of dormancy, which is similar to being in a very deep sleep and allows them to remain viable.
The bacteria will remain dormant until they come into contact with moisture, which happens after the body digests
the capsule and the MicrobacTM lipid layer in the small intestine.
Microencapsulation
In addition to protecting bacteria from stomach acid and protease enzymes, MicrobacTM stabilises probiotic bacteria to
extend their shelf life by offering protection from the external environment and exposure to light, oxygen and moisture.
Pharmaceutical-grade blister packaging
Our probiotic capsules are individually sealed in pharmaceutical-grade blister packing, which protects the bacteria
from moisture, oxygen and ultraviolet (UV) light.
Probiotics are living microorganisms which are sensitive to heat, moisture and oxygen. As such, if they are not stabilised and
appropriately packaged by the manufacturer, they will need to be kept in the fridge to remain viable. As each capsule remains individually sealed until the moment before consumption, blister packaging provides
extensive protection to probiotic bacteria by minimising exposure to environmental factors which destroy bacteria.
That’s where our probiotic products are different- we take a three-tiered approach to probiotic stability, including freeze-drying,
This level of protection is unable to be offered by alternative forms of packaging, such as jars and bottles, which
microencapsulated, and pharmaceutical blister packaging.
introduce their contents to the damaging effects of light, oxygen and moisture from the moment the seal is broken
This approach offers a level of protection superior to alternative forms of packaging, such as jars and bottles, which inadvertently (i.e. from the very beginning of supplementation).
introduce the damaging effects of oxygen and moisture to their contents from the moment the cap seal is broken.
Live Probiotic Promise
Our Live Probiotic PromiseTM guarantees that our probiotic products contain the number of probiotic bacteria stated
on the label, as a minimum, right up until the end of their shelf life, which is 24 months from their date of manufacture.
FOR PROFESSIONAL REFERENCE ONLY
PREMIUM, PRACTITIONER-ONLY PRODUCTS 11
Activated Probiotics ®
Billion Live Bacteria Strain Specificity
(BLB) The health benefits of probiotics are strain-specific. Different probiotic bacterial strains, even within the same species, can have very
different properties and activities in the human gastrointestinal tract. This is why it’s so important to know exactly which strain/s are
present in a probiotic product.
WHAT IS A PROBIOTIC STRAIN?
As in the animal kingdom, probiotic bacteria are classified according to families, genera, and species. There are over 100 different
species in the genus Lactobacillus, such as acidophilus, rhamnosus, plantarum and paracasei. When the bacteria within a single species
still exhibit significant differences, they are further classified as individual strains.
Let’s first break down the aspects of a probiotic name, for example, Lactobacillus plantarum 299v.
Lactobacillus is the genus.
The genus can be thought of as a school of bacteria.
Plantarum is a species within the Lactobacillus genus.
Each species is a specific classroom at the Lactobacillus school. Everyone in the class has similar interests, but all of
the students are still unique individuals.
299v is the specific strain within the plantarum species.
The strains are the individual students within the class, who each have different talents, do different things, and get
different grades.
With the use of innovative flow cytometry technology, we are able to count the number of actual living bacteria contained in our We identify the exact strain of each probiotic bacteria included in our products, because it is critical information to know what health
probiotics and record this number as billion live bacteria (BLB). Other measures of bacterial counts, such as colony forming units benefits it will offer.
(CFUs), cannot distinguish between living, dead and non-viable bacteria. Therefore, we use the latest technology to measure the
We use many different strains of Lactobacillus plantarum across our product range due to their different health benefits. For example,
number of metabolically active bacteria available to colonise the large intestine in each of our capsules for improved accuracy.
• Lactobacillus plantarum HEAL9 (DSM 15312) and Lactobacillus plantarum HEAL19 (DSM 31513) in Biome OsteoTM Probiotic
• Lactobacillus plantarum 299v (DSM 9843) in Biome IBSTM Probiotic.
DSM, ATCC & LMG IDENTIFICATION*
In order to further ensure accurate identification of our probiotic strains, and validate them as the exact probiotic strains used in clinical
trials, we indicate the DSM, ATCC and LMG numbers attached to our strains.
E.g. Lactobacillus plantarum 299v (DSM 9843)
These numbers are unique to a specific bacterial strain and refer to the culture collection where the reference bacteria are lodged. This
allows all of the information on each probiotic strain to be accurately tracked and traced, from culturing to clinical research and all the
way through to manufacturing.
Most of our probiotic strains are identified by a ‘DSM’ number, which is given by the DSMZ, a microorganism collection in Germany
which stores over 31,000 individual bacterial strains. Two of our strains have an ‘LMG’ number, which refers to a culture collection in
Belgium, while just one strain has an ‘ATCC’ number, which is given by the American Type Culture Collection (ATCC), which is the largest
culture collection in the world.
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PREMIUM, PRACTITIONER-ONLY PRODUCTS 13
Activated Probiotics ®
Clinical Clinically Proven
Research Products
CLINICALLY TRIALLED PROBIOTIC STRAINS CLINICALLY PROVEN PRODUCTS
All of our products contain specific probiotic strains that have a high level of clinical evidence supporting their health benefits: Specific probiotic strains are often researched in isolation, i.e. single probiotic strains are administered to people and their effects are
randomised double-blind placebo-controlled clinical trials. studied. While combining two probiotic strains to provide a greater range of health benefits may seem logical, they may not produce
the same effects when administered together.
These randomised double-blind placebo-controlled clinical trials provide important insights into the effect of specific probiotic strains
on various health outcomes in human populations, demonstrating strain-specific efficacy for a range of different health conditions. Therefore, as industry leaders, a number of our products have been clinically trialled as complete products. That means the final
product on the shelf contains the exact combination of probiotic strains at the exact same dose as the product tested in the clinical
We use probiotic strains with statistically significant effects in gold standard clinical trials to allow health practitioners concerned with
trials, making the results directly transferable to the consumer.
evidence-based practice to use our probiotic products with confidence.
We do this in order to understand the benefits of our probiotic products as a whole.
PRECISION PROBIOTICS
Because each probiotic strain offers different benefits, we have selected the most effective strains for a range of different health
conditions and aspects of health to create a range of 9 precision probiotics with targeted health benefits.
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PREMIUM, PRACTITIONER-ONLY PRODUCTS 15
Biome Osteo TM Probiotic
Biome
Osteo TM
Probiotic
To help promote bone health
in adults
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PREMIUM, PRACTITIONER-ONLY PRODUCTS 17
CLINICAL SUMMARY
Biome Osteo TM Probiotic
MEN Peak Bone Mass
WOMEN 78% REDUCTION IN BONE LOSS WITH BIOME OSTEOTM PROBIOTIC
0
Low Bone Mass -0.17%
-0.2
Biome Osteo Probiotic
Bone Mass
TM Osteoporosis
-0.4
Change in BMD (%)
Menopause
-0.6
-0.77%
To help promote bone health in adults -0.8
-1
years of
0 10 20 30 40 50 60 age
Clinically trialled in post-menopausal women -1.2
Figure 1: Changes in bone mass across the lifespan, adapted Biome OsteoTM Probiotic Placebo
Guaranteed potency from Weaver et al, 20165.
Figure 2: Percentage change in bone mineral density (BMD)
assessed at the lumbar spine by DXA. The mean change over the 12
INDICATIONS month study period was -0.17 ± 2.12% in the group supplemented
THE BURDEN OF OSTEOPOROSIS IN AUSTRALIA
with Biome Osteo™ Probiotic, compared to -0.77% ± 2.7% in the
• Biome Osteo™ may help to promote bone health in adults
Conditions characterised by low bone density - including osteopenia and placebo group. The difference between the groups was statistically
osteoporosis - affect an estimated 7.5 million Australians1. Osteoporosis significant (p=0.04).
FORMULATION causes bones to become thin, fragile and weak, and occurs when bones
Lactobacillus plantarum HEAL9 (DSM 15312) 3.3 BLB* lose minerals faster than they can be replaced. A reduction in bone
AN EMERGING ROLE OF THE GUT MICROBIOME
mineral density increases the risk of bone fractures, which can occur
Lactobacillus plantarum HEAL19 (DSM 15313) 3.3 BLB* from minor accidents, such as falling while walking. These low impact In addition to the absorption of nutrients, increasing evidence
Lactobacillus paracasei 8700:2 (DSM 13434) 3.3 BLB* fractures are known as minimal trauma fractures. As there are no obvious suggests a more complex role of the gut in the maintenance of bone
symptoms of osteoporosis, the condition often goes undiagnosed until health, mediated through the gut microbiome7. Numerous preclinical
Total live bacteria 10 BLB* a minimal trauma fracture occurs. Minimal trauma fracture of the hip trials have investigated the relationship between the gut microbiome
represents one of the most serious outcomes of osteoporosis, which and bone health in animal models, as summarised by Villa et al,
Vitamin D3 (as cholecalciferol) 60IU (1.5mcg)
occurs most commonly in women aged 80 and over2. Fractures can lead to 20177. In mouse models simulating menopause-associated estrogen
*BLB = Billion Live Bacteria
chronic pain, disability, loss of independence, and even premature death. deficiency, supplementation with lactobacilli bacteria has been
shown to protect against bone loss8, 9, 10. On the basis of encouraging
RISK FACTORS FOR OSTEOPOROSIS preclinical results, a multicenter, randomised, double-blind, placebo-
controlled trial was conducted in 2018 in Sweden to investigate the
Risk factors associated with the development of osteoporosis include
efficacy of a novel three-strain probiotic product (Biome Osteo™
being female, increasing age, family history of the condition, low vitamin
30 Vegecaps Probiotic) on maintaining bone mineral density (BMD) in 249 healthy,
PREMIUM, PRACTITIONER-ONLY PRODUCT D levels, low intake of calcium, low body weight, smoking, excess alcohol
early post-menopausal women (unpublished manuscript; currently
consumption, physical inactivity, and long-term corticosteroid use3. Women
under review).
are at greater risk of developing osteoporosis than men due to their smaller
19.4mm
bone size, lower peak bone mass, and the rapid loss of bone density which
AUST L 315633 BIOME OSTEO™ PROBIOTIC CLINICAL TRIAL
occurs following menopause (see Figure 1). After the attainment of peak
bone mass in early adulthood, bone mass remains stable for one to three The participants received Biome OsteoTM Probiotic or an identical
decades until age-related bone loss begins6 (see Figure 1). Menopause- placebo capsule daily for a period of 12 months. The primary endpoint
associated oestrogen deficiency accelerates this age-related bone loss, as of the study was the percentage change in BMD at the lumbar spine
oestrogen has a protective effect on bones. As such, particularly high rates (LS-BMD) from baseline to 12 months, as assessed by dual energy x-ray
DIRECTIONS FOR USE of bone loss are seen in the early post-menopausal period4. absorptiometry (DXA). At the end of the study period, the participants in
the intervention group had a significantly smaller percentage change in
Adults: take 1 capsule daily (with or without food), or as directed by
BONE REMODELING LS-BMD compared to the placebo group (mean change of -0.17% ± 2.12%
your healthcare practitioner.
vs. -0.77% ± 2.7%), which was statistically significant (p=0.04) (Figure
Bone is a dynamic tissue that undergoes continuous remodelling
If you are pregnant or breastfeeding – seek the advice of a 2). Further, a subgroup analysis revealed that in women who were less
throughout the lifespan, such that the entire skeleton is replaced every
healthcare practitioner before using. than six years post-menopause, the effect of the probiotic was even
10 years6. This is accomplished by the bone remodeling unit, which
Activated ProbioticsTM formulate premium more pronounced, with a percentage loss of LS-BMD of 0.18%, compared
consists of specialised cells which form new bone (osteoblasts), and
probiotic products backed by cutting edge to 1.21% in the placebo group (p=0.025). On the basis of these results,
degrade dysfunctional bone (osteoclasts) . After the attainment of Peak 6
NO ADDED scientific research on the human gut microbiome. the authors concluded that daily supplementation with Biome OsteoTM
Bone Mass in early adulthood, bone remodelling is balanced, such that
Using targeted bacterial strains at doses supported bone mass is stable for one to three decades until age-related bone loss
Probiotic reduced the loss of BMD at the lumbar spine in early post-
GMOs, wheat, gluten, dairy, lactose, fructose, yeast, nuts, seeds,
by clinical trials, we seek to provide tangible begins (see Figure 1).
6 menopausal women.
peanut, soy, egg, fish, or shellfish. No artificial colours, flavours,
improvements in health and wellbeing with a new
sweeteners, or preservatives. REFERENCES
generation of evidence-based probiotics. 1. About Osteoporosis | Osteoporosis Australia [Internet]. [cited 2019 May 8]. Available from: https://www.osteoporosis.org.au/about-osteoporosis
2. Estimating the prevalence of osteoporosis in Australia [Internet]. Australian Institute of Health and Welfare; 2014 [cited 2019 May 8]. Available from: http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=60129548481
3. Osteoporosis: musculoskeletal fact sheet [Internet]. Australian Institute of Health and Welfare; 2015 [cited 2019 May 1]. Available from: https://www.aihw.gov.au/reports/chronic-musculoskeletal-conditions/osteoporosis-musculoskeletal-fact-sheet/contents/table-of-contents
4. Ahlborg HG, Johnell O, Nilsson BE, Jeppsson S, Rannevik G, Karlsson MK. Bone loss in relation to menopause: a prospective study during 16 years. Bone. 2001 Mar;28(3):327–31.
5. Weaver CM, Gordon CM, Janz KF, Kalkwarf HJ, Lappe JM, Lewis R, et al. The National Osteoporosis Foundation’s position statement on peak bone mass development and lifestyle factors: a systematic review and implementation recommendations. Osteoporos Int. 2016 Apr;27(4):1281–386.
6. Langdahl B, Ferrari S, Dempster DW. Bone modeling and remodeling: potential as therapeutic targets for the treatment of osteoporosis. Ther Adv Musculoskelet Dis. 2016 Dec;8(6):225–35.
7. Villa CR, Ward WE, Comelli EM. Gut microbiota-bone axis. Crit Rev Food Sci Nutr. 2017 May 24;57(8):1664–72.
GMP LIVE DAIRY ONE A DAY FRIDGE VEGETARIAN 8. Britton RA, Irwin R, Quach D, Schaefer L, Zhang J, Lee T, et al. Probiotic L. reuteri Treatment Prevents Bone Loss in a Menopausal Ovariectomized Mouse Model: Probiotics suppress estrogen deficiency-induced bone loss. J Cell Physiol. 2014 Nov;229(11):1822–30.
PROBIOTIC FREE FORMULATION FREE 9. McCabe LR, Irwin R, Schaefer L, Britton RA. Probiotic use decreases intestinal inflammation and increases bone density in healthy male but not female mice. J Cell Physiol. 2013;228(8):1793–8.
PROMISE 10. Ohlsson C, Engdahl C, Fåk F, Andersson A, Windahl SH, Farman HH, et al. Probiotics Protect Mice from Ovariectomy-Induced Cortical Bone Loss. Ryffel B, editor. PLoS ONE. 2014 Mar 17;9(3):e92368.
FOR PROFESSIONAL REFERENCE ONLY
PREMIUM, PRACTITIONER-ONLY PRODUCTS 19CONDITION MANAGEMENT GUIDE SUPPORTING CLINICAL RESEARCH
Biome Osteo TM Probiotic
Biome Osteo Probiotic
Microbiol Spectr. 2017 Aug;5(4). doi: 10.1128/microbiolspec.BAD-0015-2016.
TM
THE POTENTIAL OF PROBIOTICS AS A THERAPY FOR OSTEOPOROSIS.
Collins FL, Rios-Arce ND, Schepper JD, Parameswaran N, McCabe LR
To help promote bone health in adults Osteoporosis, characterized by low bone mass and micro-architectural deterioration of bone tissue with increased risk of fracture, can be
categorized into two forms: primary and secondary, depending on whether it occurs as part of the natural aging process (estrogen deficiency) or
as part of disease pathology. In both forms bone loss is due to an imbalance in the bone remodeling process, with resorption/formation skewed
Biome Osteo™ Probiotic contains a clinically trialled more toward bone loss. Recent studies and emerging evidence consistently demonstrate the potential of the intestinal microbiota to modulate
bone health. This review discusses the process of bone remodeling and the pathology of osteoporosis and introduces the intestinal microbiota
combination of three probiotic strains (Lactobacillus
and its potential to influence bone health. In particular, we highlight recent murine studies that examine how probiotic supplementation can
plantarum HEAL9, Lactobacillus plantarum HEAL19, and both increase bone density in healthy individuals and protect against primary (estrogen deficiency) as well as secondary osteoporosis. Potential
Lactobacillus paracasei 8700:2) with vitamin D3, and may mechanisms are described to account for how probiotic treatments could be exerting their beneficial effect on bone health.
help to promote bone health in adults. The clinical trial,
conducted in Sweden in 249 post-menopausal women over
a period of 12 months, demonstrated a significant reduction
in the loss of bone mineral density (assessed at the lumbar
MECHANISM OF ACTION
spine) in the women who took the probiotic product daily,
compared to the women who received placebo.
We recommend Biome Osteo™ Probiotic as an adjunct to
BONE REMODELLING
vitamin and mineral supplements indicated for bone health
Bone is a dynamic organ, which undergoes continual remodelling throughout the lifespan. Remodelling of bone is primarily achieved by two highly
(including calcium and vitamin D3), or medications such as specialised cells: osteoblasts, which build bone, and osteoclasts, which break bone down. The process of breaking down bone is also known as bone
bisphosphonates. resorption. The immune system plays a key role in the regulation of the activity of osteoblasts and osteoclasts through the production of cytokines,
which are signalling molecules. Cytokines can either promote bone formation (i.e., their effect is ‘pro-osteogenic’) or promote bone breakdown (a ‘pro-
osteoclastogenic’ effect).
POST-MENOPAUSAL BONE LOSS
For most of adult life, the two opposing processes of bone formation and bone resorption are delicately balanced. In women, menopause is
characterised by a dramatic decline in estrogen levels, which ordinarily protects bone. As a result, women enter a period of accelerated bone loss
CONSIDER AS AN ADJUNCT TO:
after menopause. In fact, 50% of the bone loss a woman will experience in her lifetime occurs within the first 10 years after menopause. Post-
menopausal bone loss occurs in two distinct phases: an early, rapid phase, caused by increased activity of osteoclasts, and a prolonged, slower
phase, resulting from decreased osteoblast activity.
Bisphosphonates
Low levels of estrogen results in the expression of proinflammatory cytokines, including IL-6, IL-7 and TNF-α, which results in a systemic proinflammatory
Denosumab state. Further, in the gut, low estrogen levels reduce microbial abundance and diversity, weakening the ability of the microbiota to ward off
pathogenic microorganisms. Low estrogen levels also weaken the integrity of the intestinal barrier, increasing intestinal permeability. This permits
Strontium Ranelate bacterial translocation across the intestinal wall, which activates the immune system and increases the expression of pro-osteoclastogenic cytokines.
Raloxifene Biome Osteo™ Probiotic may help to promote bone health in adults, via the following mechanisms:
1. A preclinical study conducted in a mouse model showed that the novel three-strain probiotic combination of Lactobacillus paracasei 8700:2
Hormone Replacement Therapy (DSM 13434), Lactobacillus plantarum HEAL9 (DSM 15312) and Lactobacillus plantarum HEAL19 (DSM 15313) found in Biome Osteo™
Probiotic suppressed the expression of proinflammatory cytokines (TNF-α and IL-1β) and increased the expression of osteoprotegerin, an
inhibitor of osteoclastogensis, reducing osteoclast-mediated bone resorption (Ohlsson et al, 2014).
2. The intestinal epithelium provides a selective barrier that prevents translocation of harmful substances and pathogenic microorganisms from the
CONSIDER AS A COMPLEMENT TO: intestinal lumen into the bloodstream. Intestinal epithelial cells are joined by tight junction proteins, which facilitate selective transport across the
membrane. Low estrogen levels negatively affect intestinal barrier function, increasing intestinal permeability, and resulting in the production of
pro-osteoclastogenic cytokines. In a mouse model of estrogen deficiency-associated bone loss, treatment with probiotics strengthened the
intestinal epithelial barrier, reduced the formation of pro-osteoclastogenic cytokines, and protected against bone loss (Li et al 2016).
Calcium Supplements
Vitamin D3 REFERENCES
Ohlsson C, Engdahl C, Fåk F, Andersson A, Windahl SH, Farman HH, et al. Probiotics Protect Mice from Ovariectomy-Induced Cortical Bone Loss. Ryffel B, editor. PLoS ONE. 2014 Mar 17;9(3):e92368.
Ohlsson C, Sjögren K. Effects of the gut microbiota on bone mass. Trends Endocrinol Metab. 2015 Feb;26(2):69–74.
McCabe LR, Parameswaran N. Advances in Probiotic Regulation of Bone and Mineral Metabolism. Calcif Tissue Int. 2018;102(4):480–8.
Xu X, Jia X, Mo L, Liu C, Zheng L, Yuan Q, et al. Intestinal microbiota: a potential target for the treatment of postmenopausal osteoporosis. Bone Res [Internet]. 2017 Dec [cited 2019 Oct 8];5(1).
McCabe L, Britton RA, Parameswaran N. Prebiotic and Probiotic Regulation of Bone Health: Role of the Intestine and its Microbiome. Curr Osteoporos Rep. 2015 Dec;13(6):363–71.
Li J-Y, Chassaing B, Tyagi AM, Vaccaro C, Luo T, Adams J, et al. Sex steroid deficiency–associated bone loss is microbiota dependent and prevented by probiotics. J Clin Invest. 2016 Apr 25;126(6):2049–63.
Rizzoli R. Nutritional influence on bone: role of gut microbiota. Aging Clin Exp Res. 2019 Jun;31(6):743–51.
Collins FL, Rios-Arce ND, Schepper JD, Parameswaran N, McCabe LR. The Potential of Probiotics as a Therapy for Osteoporosis. Microbiol Spectr [Internet]. 2017 Aug 1 [cited 2019 Oct 8];5(4).
Jones RM, Mulle JG, Pacifici R. Osteomicrobiology: The influence of gut microbiota on bone in health and disease. Bone. 2018 Oct;115:59–67.
Quach D, Britton RA. Gut Microbiota and Bone Health. In: McCabe LR, Parameswaran N, editors. Understanding the Gut-Bone Signaling Axis [Internet]. Cham: Springer International Publishing; 2017 [cited 2019 Oct 8]. p. 47–58.
Schepper JD, Irwin R, Kang J, Dagenais K, Lemon T, Shinouskis A, et al. Probiotics in Gut-Bone Signaling. In: McCabe LR, Parameswaran N, editors. Understanding the Gut-Bone Signaling Axis [Internet]. Cham: Springer International Publishing; 2017 [cited 2019 Nov 29]. p. 225–47.
FOR PROFESSIONAL REFERENCE ONLY
PREMIUM, PRACTITIONER-ONLY PRODUCTS 21Biome Breathe TM Probiotic
Biome
Breathe TM
Probiotic
To help stimulate a healthy
immune system response in
children
FOR PROFESSIONAL REFERENCE ONLY
PREMIUM, PRACTITIONER-ONLY PRODUCTS 23CLINICAL SUMMARY GUT-LUNG AXIS
Biome Breathe TM Probiotic
Children experience significantly fewer asthma attacks with The gut microbiota is known to influence immune responses at distant
Biome Breathe TM Probiotic sites, including the lungs1. The bidirectional communication between
the gut and the lungs is described as the gut-lung axis2, and a growing
pCONDITION MANAGEMENT GUIDE J Paediatr Child Health. 2018 Sep;54(9):953-961. doi: 10.1111/jpc.14126. Epub 2018 Jul 27.
Biome Breathe TM Probiotic
PROBIOTICS SUPPLEMENTATION IN CHILDREN WITH ASTHMA: A SYSTEMATIC REVIEW AND META-ANALYSIS.
Lin J, Zhang Y, He C, Dai J.
Aim: To systematically review the effects of probiotics supplementation in children with asthma. Methods: An electronic search was conducted
Biome Breathe Probiotic
on PubMed, Embase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure Database, CQ VIP Database
TM and Wanfang Data until November 2017. The reference lists of included studies and pertinent reviews were checked for supplementing our
search. Randomised control trials that compared probiotics versus placebo were included. Results: Eleven studies with a total of 910 children
met eligibility criteria. The pooled data revealed that the proportion of children with fewer episodes of asthma was significantly higher in
To help stimulate a healthy immune system response in children the probiotics group than in the control group (risk ratio 1.3, 95% confidence interval (CI) 1.06-1.59); the reduction of IL-4 (mean differences
-2.34, 95% CI -3.38, -1.29) and the increasing of interferon-γ (mean differences 2.5, 95% CI 1.23-3.76) was also significant after the treatment of
probiotics. Nevertheless, no statistical significance was observed in childhood asthma control test, asthmatic symptoms in the day and night, the
number of symptom-free days, forced expiratory volume in the first and second predicted and peak expiratory flow. Conclusion: This systematic
review does not confirm or rule out the beneficial effects of probiotics supplementation in children with asthma. More well- designed randomised
control trials with larger sample sizes need to be conducted to evaluate the effects of probiotics in children with asthma in the future.
In a recently completed clinical trial in children with allergic asthma or
recurrent wheezing (n=422), supplementation with Biome BreatheTM
Probiotic daily for 4 months significantly reduced the number of
asthma attacks the children experienced during both the treatment
MECHANISM OF ACTION
period and 4-month follow-up period, compared to placebo1. On
the basis of these encouraging clinical trial results, Biome BreatheTM
Probiotic may be considered as an adjunct to medications indicated
MECHANISM OF ACTION - ASTHMA
for paediatric asthma management, including preventer, reliever, or
combination medications. ASTHMA AND THE HYGIENE HYPOTHESIS
Asthma is more likely to occur in those with an atopic (allergic) disposition, or a family history of atopy (allergic rhinitis, asthma, and eczema). This
indicates that there is an allergic component in many cases of asthma.
The ‘hygiene hypothesis’ contends that reduced exposure to microbes in early life means the immune system is less effectively challenged as it
matures, and may not ‘learn’ how to differentiate between harmless substances and those which are capable of triggering allergic asthma. Indeed,
recognised risk factors for asthma include factors related to altered exposure to microbes, including c-section rather than vaginal birth, absence or
short duration of breastfeeding, early childhood respiratory infections, and early life exposure to antibiotics.
Research on germ-free mice established that they exhibited significant defects in GALT (gut-associated lymphoid tissue - part of the immune
system in the gut), as well as stronger airway inflammation and airway hypersensitivity compared to mice given microbes. This research supports
CONSIDER AS AN ADJUNCT TO:
the theory that exposure to microbes is important for immunomodulation and proper airway sensitisation.
INTESTINAL DYSBIOSIS AND TH2 DOMINANCE
Asthma Preventer Medications Intestinal dysbiosis is associated with reduced epithelial barrier integrity and dominance of Th2 lymphocyte expression, where the immune
system gives an inappropriate response to environmental or food antigens. Increased Th2 lymphocyte expression leads to the secretion of pro-
Combination Preventer & Reliever inflammatory cytokines (IL-4, IL-5, IL-13, and antigen-specific IgE), and triggers eosinophilic inflammation characteristic of allergic asthma.
Reliever Medication THE LUNG MICROBIOME
Until recently, it was assumed that lung tissue was sterile. Research is now emerging that supports the hypothesis of a lung microbiome.
Differences in lung microbiota between healthy people and asthmatics, further suggesting the human microbiota may play a role in the
development of allergic asthma.
THE GUT-LUNG AXIS
There are many possible pathways which underlie the gut-lung axis communication, with microbiota-derived metabolites travelling from the gut to
the lungs (and vice versa) the current leading theory. The most researched of these are short-chain fatty acids (SCFAs), which are produced in the
gut as beneficial bacteria ferment dietary fibre. SCFAs are believed to have an immunomodulating effect on gut mucosa, reducing Th2-mediated
inflammation and potentially impacting lung-immune response.
PROBIOTICS AND IMMUNE MODULATION
Probiotics may offer a novel approach in the management of asthma. Probiotics modulate the integrity of the mucosal epithelial barrier, helping
SUPPORTING CLINICAL RESEARCH
to regulate the immune-mediated inflammatory response. They increase production of anti-inflammatory cytokines, and elevate Th1 expression,
helping to reduce the Th2 dominance seen in many cases of asthma. Mice given Bifidobacterium breve were found to have an increase in
production of regulatory T cells, which have a modulating effect on the immune system. Produced in the gut, regulatory T cells may migrate to
Allergy Asthma Immunol Res. 2015;7(4):409.
the lung, where they can provide anti-inflammatory effects. This particular probiotic was also found to induce the production of IL-10 (a cytokine
IMMUNOMODULATORY EFFECTS OF LACTOBACILLUS SALIVARIUS LS01 AND BIFIDOBACTERIUM BREVE BR03, ALONE AND IN which downregulates allergic airway inflammation) and decrease the production of IL-5 (a Th2 inflammatory cytokine).
COMBINATION, ON PERIPHERAL BLOOD MONONUCLEAR CELLS OF ALLERGIC ASTHMATICS.
In summary, probiotics may reduce the inflammation associated with asthma, and help to regulate the immune system to reduce allergic response.
Drago L, De Vecchi E, Gabrieli A, De Grandi R, Toscano M.
REFERENCES
To investigate whether specific strains of probiotic bacteria might have beneficial effects on humans with asthma, Drago et al isolated peripheral Anand S, Mande S. Diet, Microbiota and Gut-Lung Connection. Frontiers in Microbiology [Internet]. 2018 [cited 2019 Oct 23];
blood mononuclear cells (PBMCs) from patients with allergic asthma, and incubated them with two probiotic strains (Lactobacillus salivarius and Australian Institute of Health and Welfare. Asthma. Canberra: AIWH; 2019
Frati F, Salvatori C, Incorvaia C, Bellucci A, Di Cara G, Marcucci F, et al. The Role of the Microbiome in Asthma: The Gut–Lung Axis. International Journal of Molecular Sciences [Internet]. 2018 [cited 2019 Oct 22];(1):123.
Bifidobacterium breve) alone and in combination, creating three different incubation conditions. The experiment showed a statistically significant increase Hajavi J, Esmaeili S-A, Varasteh A-R, Vazini H, Atabati H, Mardani F, et al. The immunomodulatory role of probiotics in allergy therapy. Journal of Cellular Physiology [Internet]. 2019 [cited 2019 Oct 22];(3):2386.
in IL-10 secretion from PBMCs under all three conditions. IL-10 is an anti-inflammatory cytokine, and is a powerful inhibitor of pro-inflammatory cytokines, Ozturk AB, Turturice BA, Perkins DL, Finn PW. The Potential for Emerging Microbiome-Mediated Therapeutics in Asthma. Current Allergy and Asthma Reports [Internet]. 2017 [cited 2019 Oct 21];17(9):1.
Sokolowska M, Frei R, Lunjani N, Akdis C, O’Mahony L. Microbiome and asthma. Asthma Research and Practice [Internet]. 2018 [cited 2019 Oct 21];(1):1.
including IL-4 and IL-5, produced by Th2 lymphocytes. The authors concluded that these two strains may act as anti-inflammatory mediators able to
Toh Z, Anzela A, Tang M, Licciardi P. Probiotic therapy as a novel approach for allergic disease. Front. Pharmacol [Internet]. 2012 Sep [cited 2019 Oct 22].
inhibit the Th2 cytokine profile that is increased in allergic diseases, and demonstrated immunomodulatory activity in combination. Wilson NG, Hernandez-Leyva A, Kau AL. The ABCs of wheeze: Asthma and bacterial communities. PLoS Pathogens [Internet]. 2019 Apr 25 [cited 2019 Oct 21];15(4):1–7.
FOR PROFESSIONAL REFERENCE ONLY
PREMIUM, PRACTITIONER-ONLY PRODUCTS 27Biome Lift TM Probiotic
Biome
Lift TM
Probiotic
To support healthy mood
balance and enhance
sleep quality
FOR PROFESSIONAL REFERENCE ONLY
PREMIUM, PRACTITIONER-ONLY PRODUCTS 29CLINICAL SUMMARY
Biome Lift TM Probiotic
BIOME LIFT TM PROBIOTIC SIGNIFICANTLY REDUCES MEASURES OF DEPRESSED MOOD, ANGER, AND FATIGUE
A: DEPRESSED MOOD B: ANGER C: FATIGUE
18 * 18 * 18 *
Biome Lift TM
Probiotic
16 * 16 * 16 * Biome Lift™
* Placebo
14 14 14
Questionnaire median score
To support healthy mood balance and enhance sleep quality 12 12 12
10 10 10
8 8 8
Natural mood support
6 6 6
Clinically trialled probiotic product
4 4 4
Microbac™ technology: 5x more effective delivery
2 2 2
Guaranteed potency
0 0 0
T0 T1 T2 T3 T0 T1 T2 T3 T0 T1 T2 T3
Figure 2: Median Profile of Mood States (POMS) subscale scores from the participants in the Biome Lift™ group and the placebo group.
INDICATIONS
Error bars represent 95% confidence interval. Asterisks indicate within-group significant differences (Bonferroni corrected pCONDITION MANAGEMENT GUIDE SUPPORTING CLINICAL RESEARCH
Biome Lift TM Probiotic
Biome Lift Probiotic
J Altern Complement Med. 2016 Nov 14;23(4):249–58.
TM
PROBIOTICS AND SUBCLINICAL PSYCHOLOGICAL SYMPTOMS IN HEALTHY PARTICIPANTS: A SYSTEMATIC REVIEW AND META-ANALYSIS.
McKean J, Naug H, Nikbakht E, Amiet B, Colson N.
To support healthy mood balance and enhance sleep quality Introduction: Interest in the gut-brain axis and emerging evidence that the intestinal microbiota can influence central nervous system function has
led to the hypothesis that probiotic supplementation can have a positive effect on mood and psychological symptoms such as depression and
anxiety. Although several human clinical trials have investigated this, results have been inconsistent.
Biome Lift™ Probiotic is an exclusive probiotic formulation Aim: A systematic review and meta-analytic approach was chosen to examine if probiotic consumption has an effect on psychological symptoms.
Methods: The online databases PubMed, Scopus, and the Cochrane Library were searched for relevant studies up to July 2016. Those that were
clinically proven to reduce depressed mood, anger, and fatigue,
randomized and placebo controlled and measured preclinical psychological symptoms of depression, anxiety, and perceived stress in healthy
and improve sleep quality in healthy adults (1). volunteers pre and post supplementation with a probiotic were included.
Results: Seven studies met the inclusion criteria and provided data for nine comparisons. All studies passed the quality analysis. The meta-analysis
Biome Lift™ Probiotic is indicated to support healthy mood showed that supplementation with probiotics resulted in a statistically significant improvement in psychological symptoms (standardized mean
difference 0.34; 95% confidence interval 0.07-0.61, Z = 2.49) compared with placebo.
balance, and can be prescribed as a complement or alternative
Conclusion: These results show that probiotic consumption may have a positive effect on psychological symptoms of depression, anxiety, and
to listed medicines which support a healthy mood, such as St. perceived stress in healthy human volunteers.
John’s Wort.
Biome Lift™ Probiotic is also indicated to enhance sleep quality,
and can be prescribed as a complement or alternative to herbal MECHANISM OF ACTION
preparations such as valerian, passionflower, and hops.
BACKGROUND
Numerous animal studies (in mice and rats) have shown that probiotics can reduce depressive and anxiety-like behaviours. These observations
have been replicated in clinical trials in humans, with a recent systematic review and meta-analysis concluding that ‘probiotic consumption may
have a positive effect on psychological symptoms of depression, anxiety, and perceived stress in healthy human volunteers’ (McKean et al, 2017).
The mechanisms of action by which probiotics can exert benefits on our mood are largely speculative and not well-defined, but are believed to be
mediated via the microbiota-gut-brain axis.
Interestingly, depression is associated with compositional differences in the gut microbiota compared to healthy controls. One study which transferred
CONSIDER AS AN ADJUNCT TO:
gut microbiota from depressed human patients into healthy rats (via faecal microbiota transplantation) induced the behavioural and physiological
features of depression in the rats, including anhedonia (inability to feel pleasure in normally pleasurable activities) and anxiety-like behavior (Kelly et al,
Antidepressant Medications 2016).The pathophysiology of depression involves:
• Brain abnormalities, including unbalanced neurotransmitters, impaired neuroplasticity, and abnormal neural circuitry
Medications for Sleeping Difficulties
• Dysfunction of the hypothalamic pituitary adrenal (HPA) axis, which coordinates the body’s response to physical and psychological stress
• Chronic inflammation, resulting from an increase in pro-inflammatory cytokines and reduction in anti-inflammatory cytokines
• Dysfunction in the microbiota-gut-brain axis, i.e. the bidirectional communication between the gut and the brain via neural, immune and
endocrine pathways, influenced by the gut microbiota
DEPRESSION AS AN INFLAMMATORY CONDITION
This chronic low-grade inflammation seen in depressed patients is thought to be caused in part by increased intestinal permeability (“leaky gut”, which
can be induced by chronic stress), which allows bacterial endotoxins (lipopolysaccharide or LPS) to translocate into the bloodstream, triggering the
release of pro-inflammatory cytokines. Probiotics strengthen the integrity of the gut barrier (reducing permeability), which prevents the translocation
CONSIDER AS A COMPLEMENT TO: of LPS and subsequent inflammation.
The mechanisms by which probiotics modulate brain function (including cognition, mood and emotional state) is thought to be related to their ability to:
• Produce neurotransmitters, including GABA and dopamine
St John's Wort • Modulate the activity of the immune system, decreasing pro-inflammatory cytokine production
• Produce neuromodulators, such as short-chain fatty acids (via the fermentation of fibre)
Valerian • Enhance barrier function, preventing bacterial translocation (and immune activation)
REFERENCES
Foster JA, McVey Neufeld K-A. Gut–brain axis: how the microbiome influences anxiety and depression. Trends Neurosci. 2013 May;36(5):305–12.
McKean J, Naug H, Nikbakht E, Amiet B, Colson N. Probiotics and Subclinical Psychological Symptoms in Healthy Participants: A Systematic Review and Meta-Analysis. J Altern Complement Med. 2017 Apr;23(4):249–58.
Liu X, Cao S, Zhang X. Modulation of Gut Microbiota–Brain Axis by Probiotics, Prebiotics, and Diet. J Agric Food Chem. 2015 Sep 16;63(36):7885–95.
Jiang H, Ling Z, Zhang Y, Mao H, Ma Z, Yin Y, et al. Altered fecal microbiota composition in patients with major depressive disorder. Brain Behav Immun. 2015 Aug;48:186–94.
Kelly JR, Borre Y, O’ Brien C, Patterson E, El Aidy S, Deane J, et al. Transferring the blues: Depression-associated gut microbiota induces neurobehavioural changes in the rat. J Psychiatr Res. 2016;82:109–18.
Liang S, Wu X, Hu X, Wang T, Jin F. Recognizing Depression from the Microbiota–Gut–Brain Axis. Int J Mol Sci [Internet]. 2018 May 29 [cited 2019 Nov 1];19(6).
REFERENCES Wallace CJK, Milev R. The effects of probiotics on depressive symptoms in humans: a systematic review. Ann Gen Psychiatry [Internet]. 2017 Dec [cited 2019 Oct 31];16(1).
Marotta A, Sarno E, Del Casale A, Pane M, Mogna L, Amoruso A, et al. Effects of Probiotics on Cognitive Reactivity, Mood, and Sleep Quality. Front Psychiatry [Internet]. 2019 Mar 27 [cited 2019 May 31];10. Available from: https://www.frontiersin.org/article/10.3389/fpsyt.2019.00164/ful Kelly JR, Kennedy PJ, Cryan JF, Dinan TG, Clarke G, Hyland NP. Breaking down the barriers: the gut microbiome, intestinal permeability and stress-related psychiatric disorders. Front Cell Neurosci [Internet]. 2015 Oct 14 [cited 2019 Nov 8];9.
FOR PROFESSIONAL REFERENCE ONLY
PREMIUM, PRACTITIONER-ONLY PRODUCTS 33Biome IBS TM Probiotic
Biome
IBS TM
Probiotic
To relieve the symptoms of
medically diagnosed Irritable
Bowel Syndrome
FOR PROFESSIONAL REFERENCE ONLY
PREMIUM, PRACTITIONER-ONLY PRODUCTS 35CLINICAL SUMMARY
Biome IBS TM Probiotic
Lactobacillus plantarum 299v significantly reduces IBS symptoms Lactobacillus rhamnosus GG significantly reduces IBS symptoms
L. plantarum 299v Placebo L. rhamnosus GG Normal diet (ND)
500
A: ABDOMINAL PAIN B: BLOATING
1.4 1.4
Biome IBS TM
Probiotic 1.2 1.2
400
IBS-SSS Total Score
Mean score of severity
1 * 1 300
*
To relieve the symptoms of medically diagnosed Irritable Bowel Syndrome 0.8 * 0.8
200
0.6 0.6 *
*
100
0.4 0.4
Targets the upper and lower GI tract for effective IBS relief 0.2 0.2 0
Week 0 Week 6
Clinically trialled probiotic strains 0 0
Baseline Week 2 Week 3 Week 4 Baseline Week 2 Week 3 Week 4 Figure 2:
Microbac™ technology: 5x more effective delivery Figure 1: Box plot of IBS Symptom Severity Score (IBS-SSS) total score in
Changes in IBS symptom severity in patients in the Lactobacillus patients with IBS in the Lactobacillus rhamnosus GG and normal
Guaranteed potency plantarum 299v (n= 108) and placebo groups (n=106) over the diet (ND) groups at baseline and week 6. At the end of the 6 week
4-week treatment period. *pCONDITION MANAGEMENT GUIDE SUPPORTING CLINICAL RESEARCH
Biome IBS TM Probiotic
World J Gastroenterol. 2012 Aug 14;18(30):4012-8. doi: 10.3748/wjg.v18.i30.4012.
Biome IBS TM
Probiotic CLINICAL TRIAL: LACTOBACILLUS PLANTARUM 299V (DSM 9843) IMPROVES SYMPTOMS OF IRRITABLE BOWEL SYNDROME.
Ducrotté P, Sawant P, Jayanthi V.
Aim: To assess the symptomatic efficacy of Lactobacillus plantarum 299v (L. plantarum 299v) (DSM 9843) for the relief of abdominal symptoms in a
To relieve the symptoms of medically diagnosed Irritable Bowel Syndrome large subset of irritable bowel syndrome (IBS) patients fulfilling the Rome III criteria.
Methods: In this double blind, placebo-controlled, parallel-designed study, subjects were randomized to daily receive either one capsule of L. plantarum
299v (DSM 9843) or placebo for 4 wk. Frequency and intensity of abdominal pain, bloating and feeling of incomplete rectal emptying were assessed
As the underlying pathophysiology of the condition is complex weekly on a visual analogue scale while stool frequency was calculated.
Results: Two hundred and fourteen IBS patients were recruited. After 4 wk, both pain severity (0.68 + 0.53 vs 0.92 + 0.57, P < 0.05) and daily frequency
and likely multifactorial, treatment options are limited in their
(1.01+ 0.77 vs 1.71 + 0.93, P < 0.05) were lower with L. plantarum 299v (DSM9843) than with placebo. Similar results were obtained for bloating. At week
effectiveness and aim to manage the most distressing symptoms, such 4, 78.1 % of the patients scored the L. plantarum 299v (DSM 9843) symptomatic effect as excellent or good vs only 8.1 % for placebo (PBiome Iron+ TM Probiotic
Biome
Iron+ TM
Probiotic
To help increase absorption of
dietary iron
FOR PROFESSIONAL REFERENCE ONLY
PREMIUM, PRACTITIONER-ONLY PRODUCTS 41CLINICAL SUMMARY IRON DEFICIENCY
Biome Iron+ TM Probiotic
Lactobacillus plantarum 299v increases dietary iron absorption Iron deficiency remains the most common nutritional deficiency in
Australia. Iron deficiency is a deficit of total body iron due to an
A: Fruit drink B: Encapsulated
30 inadequate dietary intake, excessive losses, or inadequate absorption.
49%
25
increase Symptoms of iron deficiency include fatigue, headaches, shortness of
28.8% 23%
Biome Iron+ Probiotic
Iron absorption (%)
breath, pale skin and hair loss.
TM 20 23.4%
increase
POPULATION GROUPS AT HIGHER RISK OF IRON DEFICIENCY
15 19.3% 19.1%
• Menstruating women, particularly women with heavy bleeding
To help increase absorption of dietary iron 10
• Female athletes, particularly distance runners
5
• Pregnant women, due to increased requirements
0 • Regular blood donors
Lactobacillus Control Lactobacillus Control
Significantly boosts iron absorption plantarum 299v plantarum 299v • People with chronic bowel diseases such as Coeliac disease
Figure 1: • Vegetarians and vegans, particularly if their diet is poorly planned
Clinically trialled probiotic product a. Iron absorption from an iron-fortified fruit drink enriched with
• Infants and young children, who have high iron needs
Lactobacillus plantarum 299v7. In two separate clinical trials,
Guaranteed potency • People who have undergone bariatric procedures
healthy menstruating women (n=21 in total) were served the fruit
drink either with or without Lactobacillus plantarum 299v as a • Patients on certain medications, such as proton pump inhibitors (PPIs)1
light breakfast meal. Iron absorption was assessed using a double
INDICATIONS isotope technique, which is considered the present gold standard IRON SUPPLEMENTS
• Biome Iron+™ helps increase absorption of dietary iron method for assessing iron absorption. The pooled results The first-line therapy for the treatment of iron deficiency is a course
from trials 1 and 2 showed a statistically significant increase of oral iron supplementation, providing 30-100mg elemental iron
in iron absorption of 49% from the fruit drink enriched with per day2. High dose iron supplements are typically in the form of a
FORMULATION
Lactobacillus plantarum 299v, compared to placebo (pCONDITION MANAGEMENT GUIDE SUPPORTING CLINICAL RESEARCH
Biome Iron+ TM Probiotic
Biome Iron+ Probiotic
PLoS One. 2017 Dec 13;12(12):e0189141. doi: 10.1371/journal.pone.0189141. eCollection 2017.
TM
FREEZE-DRIED LACTOBACILLUS PLANTARUM 299V INCREASES IRON ABSORPTION IN YOUNG FEMALES - DOUBLE ISOTOPE
SEQUENTIAL SINGLE-BLIND STUDIES IN MENSTRUATING WOMEN.
Hoppe M, Önning G, Hulthén L.
To help increase absorption of dietary iron
Background: The probiotic strain Lactobacillus plantarum 299v has earlier been shown to increase iron absorption when added to foods. However,
it is not known if the same probiotic strain in a freeze-dried format included in a capsule increases the iron absorption. Objective: The aim of this
Many population groups struggle to maintain normal iron study was to test the hypotheses that non-heme iron absorption from a light meal is promoted by a simultaneous intake of freeze-dried Lactobacillus
plantarum 299v (Lp299v, DSM 9843). Methods: With a single blinded placebo controlled sequential design, iron absorption from a light breakfast
levels, including menstruating women (particularly those with
meal administered with or without capsules containing 1010 cfu freeze-dried Lp299v was studied in healthy female volunteers of fertile age. The
heavy periods), pregnant women, vegetarians and vegans, and methodology used was a double isotope technique (59Fe and 55Fe). Two studies were performed using the same protocol.
people with chronic bowel diseases, such as Coeliac disease.
Results: In study 1, the absorption of iron from a meal without Lp299v was found to be 17.4 ± 13.4%, and from an identical meal with Lp299v was
Biome Iron+TM Probiotic contains Lactobacillus plantarum found to be 22.4 ± 17.3% (mean ± SD). This difference was statistically significant (p = 0.040, n =14). In study 2, the absorption of iron from a meal
299v, a probiotic strain clinically proven to increase the without Lp299v was found to be 20.9 ± 13.1%, and from an identical meal with Lp299v found to be 24.5 ± 12.0% (mean ± SD, n = 28), which again was
absorption of dietary iron . We recommend prescribing Biome 1 statistically significant (p = 0.003).
Iron+TM Probiotic as a stand-alone product, or iron supplements Conclusion: Freeze-dried Lp299v enhances the absorption of iron when administered together with a meal with a high iron bioavailability.
to help maintain normal iron levels in the body. Biome Iron+ TM
Probiotic is safe for use in pregnancy, and can be used
alongside prenatal vitamin and mineral supplements.
MECHANISM OF ACTION
ABSORPTION OF DIETARY IRON
Iron is present in food as heme and non-heme iron. Plant foods contain non-heme iron only, whereas animal foods contain both heme and non-heme
iron. Heme iron is more efficiently absorbed than non-heme iron.
CONSIDER AS AN ADJUNCT TO: Non-heme iron in the gastrointestinal tract is mostly present in the oxidised form, ferric iron (Fe3+). Ferric iron (Fe3+) needs to be reduced to ferrous
iron (Fe2+) before it can be transported into the duodenal enterocyte through the transporter DMT-1. Ferric iron can be reduced in the lumen by
ascorbic acid (or other reducing agents), or the membrane-spanning reductase duodenal cytochrome B (dcytb).
Oral Iron Supplements The mechanisms by which Lactobacillus plantarum 299v (in Biome Iron+ Probiotic) enhances iron absorption are still being elucidated, but are
believed to be via several different mechanisms, including:
• Lactobacillus plantarum species produce a molecule with ferric-reducing activity (p-hydroxy-phenyllactic acid; HPLA). HPLA reduces ferric iron to
the more bioavailable ferrous iron
• A recent in vitro study conducted in a human epithelial cell model demonstrated that in the presence of Lactobacillus plantarum 299v, there was an
increase in the expression of duodenal cytochrome b (Dcytb), also known as ferrireductase, an enzyme which reduces ferric iron (Fe3+) to ferrous
iron (Fe2+), which is the form of iron readily transported into duodenal enterocytes.
• In summary, Lactobacillus plantarum 299v most likely increases the bioavailability of non-heme iron, enhancing its absorption from the intestine by
increasing the amount of ferric iron (Fe3+) in the intestine.
CONSIDER AS A COMPLEMENT TO:
Low Dose Oral Iron Supplements
REFERENCES
Y. Suzuki, M. Kosaka, K. Shindo, T. Kawasumi, H. Kimoto-Nira and C. Suzuki. Identification of Antioxidants Produced by Lactobacillus plantarum, Biosci. Biotechnol. Biochem., 2013, 77, 1299–1302.
REFERENCES Sandberg A-S, Önning G, Engström N, Scheers N. Iron Supplements Containing Lactobacillus plantarum 299v Increase Ferric Iron and Up-regulate the Ferric Reductase DCYTB in Human Caco-2/HT29 MTX Co-Cultures. Nutrients. 2018 Dec 8;10(12):1949.
1. Hoppe M, Önning G, Hulthén L. Freeze-dried Lactobacillus plantarum 299v increases iron absorption in young females—Double isotope sequential single-blind studies in menstruating women. van Wouwe JP, editor. PloS one. 2017 Dec 13;12(12):e0189141. Hoppe M, Önning G, Hulthén L. Freeze-dried Lactobacillus plantarum 299v increases iron absorption in young females—Double isotope sequential single-blind studies in menstruating women. van Wouwe JP, editor. PLoS ONE. 2017 Dec 13;12(12):e0189141.
FOR PROFESSIONAL REFERENCE ONLY
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