Report Demonstrates Effects of Bacteria Within and Beyond the Gut

Alimentary Health (AH) Limited announces the results of the first report to demonstrate the ability of the specific probiotic, B. infantis 35624, to reduce systemic inflammatory tone in both gastrointestinal and non-gastrointestinal related disorders in three separate randomised double-blind placebo controlled intervention studies.

These results have been published in the leading peer-reviewed journal, Gut Microbes (4:4, 1-5; July/August 2013).

There is persuasive evidence from several sources indicating that the gut microbiota has an influence on the development and maintenance not only of the mucosal [1],[2] but also the systemic immune response[3],[4].

Scientists from Alimentary Health Ltd. and the Alimentary Pharmabiotic Centre, University College Cork fed B. infantis 35624 for 6-8 weeks to patients with the gastrointestinal disorder ulcerative colitis and also to patients suffering from two common non-gastrointestinal inflammatory diseases: the skin condition psoriasis and chronic fatigue syndrome. At baseline, both gastrointestinal (UC) and non-gastrointestinal (CFS and psoriasis) patients had significantly increased blood levels of C-reactive protein (CRP) and the pro-inflammatory cytokines, tumor necrosis factor α (TNF-α) and interleukin-6 (IL-6), compared with healthy volunteers. CRP and cytokines are proteins found in the blood that act as inflammatory markers; levels of both rise in response to inflammation.

Compared to the placebo control, the researchers found that across all three inflammatory disorders, patients experienced significantly reduced levels of inflammatory markers: in particular, patients who received B. infantis 35624 had significantly lower CRP levels in their blood compared with placebo, while TNF-α was reduced in CFS and psoriasis and IL-6 was reduced in UC and CFS. In general, reductions in inflammatory markers, such as those seen in this study, would be indicative of clinical remission and a lower risk of relapse. This is the first paper to show that a probiotic consistently reduced inflammation markers across multiple conditions and comprehensively shows, the immune modulating potential of the probiotic strain B. infantis 35624 in humans.

Commenting on the results Professor Eamonn Quigley, Chief, Division of Gastroenterology and Hepatology, Houston Methodist Hospital and Weill Cornell College of Medicine, Houston, Texas, said:

"Some probiotics alter the immune system in animal studies but few translate the effects to humans. What is impressive about these results is that not only are they from human subjects, but from individuals with common inflammatory conditions. In these results we are clearly seeing the impact of a probiotic organism in human disease; this raises the exciting prospect of new strategies using specific probiotics to modify the body's systemic immune response from within the gut."

Professor Fergus Shanahan, Professor of Medicine and Director of the Alimentary Pharmabiotic Centre, University College Cork commented:

"This work shows the ability of a single microbe to reduce systemic pro-inflammatory biomarkers in both gastrointestinal and non-gastrointestinal conditions and demonstrates the ability of certain probiotics to act beyond the gut."

This study is further confirmation of the therapeutic versatility of AH's proprietary strain B. infantis 35624, already commercialised in the USA, as the active ingredient in the Align® brand, the most highly recommended probiotic by US gastroenterologists for Irritable Bowel Syndrome (IBS).

AH CEO Barry Kiely commented:

"These results show the potential for carefully selected probiotics to manage the underlying inflammation across a number of chronic conditions; and we are proud of AH's pioneering contribution to the field. Underlining our core capability in strain discovery and application, this work is another significant milestone in AH's strategy of developing clinically-validated nutrition-based products for dietary management of selected conditions, which are regulated through medical foods and food for special medical purposes."

Notes for editors:

About Alimentary Health Ltd (AH)

AH is a specialty Irish biotechnology company which is focused on the discovery, development and commercialisation of proprietary probiotic and pharmabiotic treatments for gastro-intestinal disorders and other inflammatory conditions. At the forefront of research and discovery of third generation probiotics; AH is the foundation industry partner of the Alimentary Pharmabiotic Centre based at University College Cork, Ireland. The APC, a leading probiotics research centre, has just received a combined investment of €50m by the Irish Government and industry.

About B. infantis 35624:

One of a number of so-called 'smart strains' within the AH portfolio, B. infantis 35624 is a third-generation microbe developed by AH in Ireland and commercialised in the US and Canada as the number one Gastroenterologist recommended brand Align® for IBS by Procter & Gamble. 3rd Generation probiotics are strains that have been selected for the right job. B. infantis 35624 is a 3rd Generation strain because of its unique ability to manage all the symptoms of IBS, unlike other strains and selectively reduce pro-inflammatory markers.

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2. Garrett WS, Gordon JI, Glimcher LH. Homeostasis and inflammation in the intestine. Cell 2010; 140:859-70.

3. Lee YK, Menezes JS, Umesaki Y, Mazmanian SK. Proinflammatory T-cell responses to gut microbiota promote experimental autoimmune encephalomyelitis. Proceedings of the National Academy of Sciences of the United States of America 2011; 108 Suppl 1:4615-22.

4. Wu HJ, Ivanov, II, Darce J, Hattori K, Shima T, Umesaki Y, et al. Gut-residing segmented filamentous bacteria drive autoimmune arthritis via T helper 17 cells. Immunity 2010; 32:815-27.