Recent Study Confirms Alimentary Health's Bifantis® Demonstrates Efficacy in the Treatment of Irritable Bowel Syndrome
Cork Ireland, October 16, 2007 Alimentary Health Ltd. (Alimentary Health), the development stage specialty biotechnology company, announces that a recent study evaluating the use of probiotics in the treatment of Irritable Bowel Syndrome (IBS) has found that Bifidobacterium infantis 35624, the Alimentary Health probiotic technology marketed as Bifantis®, is the only probiotic currently able to demonstrate efficacy for improvement in IBS symptoms.
Alimentary Health is a leader in pioneering the development of safe and effective therapeutics for Gastrointestinal (GI) and other indications. Bifantis has been clinically proven to manage a full range of episodic digestive upsets, including constipation, diarrhea, abdominal discomfort, urgency, gas and bloating. Bifantis is only found in the daily probiotic supplement Align® which is being marketed by Procter & Gamble (NYSE: PG) in the U.S. under a current licensing agreement with Alimentary Health.
The study, published in The American Journal of Gastroenterology and presented this week at the annual American College of Gastroenterology (ACG) conference taking place in Philadelphia, PA, involved a systematic review of randomized control trials ("RCTs") to evaluate the efficacy, safety and tolerability of probiotics in the treatment of IBS.
Of the 13 RCTs that met the appropriate selection criteria, the only probiotic to demonstrate significant improvement in IBS symptoms was Bifidobacterium infantis 35624. Further information about the trial can be found in the notes to editors.
Barry Kiely, CEO of Alimentary Health, commented: "This review is a clear independent assessment of where Bifantis/Align is positioned in terms of efficacy against other probiotic studies. There are currently no other IBS therapeutics on the market that demonstrate such superior efficacy and safety. This research supports the recent decision by Procter & Gamble to undertake further clinical evaluation of Alimentary Health's probiotic technology, and we look forward to further endorsement of our product following this week's presentation at the annual ACG conference in Philadelphia, PA."
Contact Information: Financial Dynamics:
Tel: +44 (0) 20 7269 7182 Deborah Scott/Lara Mott
Notes to Editors:
About Alimentary Health
Alimentary Health is a development stage specialty biotechnology company located in Ireland. The company is focused on the discovery, development and commercialization of proprietary probiotic and pharmabiotic treatments for gastrointestinal disorders and other inflammatory conditions. Alimentary Health is the foundation industry partner of the Alimentary Pharmabiotic Center based at University College Cork, Ireland.
Website: www.alimentaryhealth.ie
About Align®
Align is a daily dietary supplement that works naturally to help build and maintain a healthy, balanced digestive system.* Align works by providing a natural defense against common digestive upsets such as constipation, diarrhea, abdominal discomfort, urgency, gas, and bloating. Bifantis® is the natural probiotic ingredient in Align. The specific and pure strain of Bifantis found in Align - Bifidobacterium infantis 35624 - is clinically proven to build and maintain a strong, healthy digestive system. It does this by helping establish a healthy gastrointestinal flora. Align is the only probiotic supplement that contains Bifantis.*
Website: www.aligngi.com
About Procter & Gamble (NYSE:PG)
Procter & Gamble (P&G) has one of the strongest portfolios of trusted, quality, leadership brands including Pampers®, Tide®, Ariel®, Always®, Whisper®, Pantene®, Mach3®, Bounty®, Dawn®, Pringles®, Folgers®, Charmin®, Downy®, Lenor®, Iams®, Crest®, Oral-B®, Actonel®, Duracell®, Olay®, Head & Shoulders®, Wella, Gillette®, and Braun. The P&G community consists of almost 140,000 employees working in over 80 countries worldwide.
Website: www.pg.com
*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. Extract from The American Journal of Gastroenterology
The Utility of Probiotics in the Treatment of Irritable Bowel Syndrome: A Systematic Review Darren M. Brenner, MD, Matthew Moeller, MD, Willton D. Chey, MD, Philip Schoenfeld, MD*. Department of Gastroenterology, University of Michigan Hospitals, Ann Arbor, MI and Department of Internal Medicine, University of Michigan Hospitals, Ann Arbor, MI.
Purpose: To perform a systematic review of randomized controlled trials (RCTs) evaluating the efficacy, safety and tolerability of probiotics in the treatment of IBS.
Methods: Searches of MEDLINE, PUBMED, EMBASE and COCHRANE databases were performed to identify the appropriate studies.Study selection criteria: (1) study design-randomized controlled trials (RCT),; (2) study population-adults with IBS defined by Manning or Rome II criteria;, (3) intervention-single or combination probiotic versus placebo; (4) outcome-improvement in IBS symptoms and frequency of adverse events. Data about quality of study design based upon Rome Committee recommendations was also extracted. Data were extracted in duplicate. Due to extreme variability in study design, study dosage, and outcome measures, quantitative pooling of data was not feasible.
Results: 13 RCTs met selection criteria. 11/13 studies demonstrated sub-optimal study design with inadequate blinding, inadequate trial length, inadequate sample size, and lack of ITT analysis. Only three studies provided any quantifiable data about tolerability and adverse events. The only probiotic to demonstrate significant improvement in IBS symptoms in appropriately designed studies was Bifidobacterium infantis 35624 (Align®, Proctor & Gamble).
In the first, Bifidobacterium infantis 35624 resulted in significant improvement in the composite score abdominal pain/discomfort, bloating/distention and bowel movement difficulty compared to placebo for the entire treatment period. In a subsequent study, Bifidobacterium infantis 35624 again demonstrated superior efficacy to placebo for the primary outcome measure abdominal pain/discomfort as well as the secondary measures bloating/distention, incomplete evacuation, straining, passage of gas and a composite score of abdominal pain/discomfort, bloating/distention, and bowel movement satisfaction at the a priori time point four weeks.
Conclusion: Bifidobacterium infantis 35624 has demonstrated efficacy for improvement in IBS symptoms.There is inadequate data to comment on the efficacy of other probiotics. Most trials do not provide adequate data about safety and tolerability. Future RCTs should follow Rome recommendations for appropriate design of an RCT and should provide precise data on tolerability and adverse events.
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