Review of Probiotic Trial Research Finds Only Bifantis Able to Claim Efficacy versus Placebo for IBS Symptoms

Of 13 studies analyzed, only Bifantis used appropriate study design to demonstrate efficacy compared with placebo

PHILADELPHIA, October 15, 2007 /PRNewswire/ -- A new analysis of randomized controlled trials evaluating probiotics in the treatment of irritable bowel syndrome (IBS) has found that Bifantis(R), Bifidobacterium infantis 35624, the sole ingredient in Align(R) (manufactured by Procter & Gamble), is the only probiotic currently able to demonstrate significant improvement in IBS symptoms based upon a properly designed research study. Researchers at the University of Michigan conducted the review to evaluate the safety, efficacy and tolerability of probiotics for IBS in randomized controlled trials and found that, with the exception of the Bifidobacterium infantis 35624 studies, most were not designed in a way that made the data possible to validate. The review data were presented this week at the annual of Gastroenterology (ACG) conference taking place in Philadelphia, PA.

"There is growing interest in medical and patient communities about the use of probiotics in IBS and lots of data has been published about this topic, but it's helpful to know the quality of that data before making a treatment decision," said Darren Brenner, MD, lead investigator on this project. "Our analysis showed that only this particular strain of probiotic, Bifidobacterium infantis 35624, has valid data for successfully treating IBS symptoms. At this point, we just don't have enough valid data to determine if other probiotics are effective for IBS."

The Study

The goal of this systematic review of randomized controlled trials was to evaluate the efficacy, safety and tolerability of probiotics in the treatment of IBS. Criteria for the study included randomized controlled trials testing adults with IBS symptoms using single or combination probiotics versus placebo for IBS symptoms and frequency of adverse events.

Of the 13 trials that met selection criteria, 11 demonstrated sub-optimal study design with inadequate blinding, inadequate trial length, inadequate sample size and lack of proper analysis. Only three studies provided quantifiable data about tolerability and adverse events, and the only probiotic to demonstrate significant improvement in IBS symptoms in appropriately designed studies was Bifidobacterium infantis 35624.

Bifidobacterium infantis 35624 showed significant improvement in the composite score of abdominal pain/discomfort, bloating/distention and bowel movement difficulty compared with placebo. A subsequent study showed that Bifidobacterium infantis 35624 demonstrated superior efficacy to the placebo for the primary outcome measure of abdominal pain/discomfort as well as for secondary measures including bloating/distention, incomplete evacuation, straining and passage of gas.

"From our discovery of the bacterium to the description of its genome and biological properties and, finally, to the clinical studies that have made this available to consumers in Align, our primary goal has been to provide accurate information on the benefits of Bifantis," said Eamonn Quigley, MD FACG and professor of Medicine and Human Physiology and Head of the Medical School, National University of Ireland (NUI).

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. Please visit www.alimentaryhealth.ie for more information.

About APC

The Alimentary Pharmabiotic Centre (APC) is a Science Foundation Ireland (SFI) funded research centre headquartered in University College Cork (UCC), with scientists and clinicians also based in Teagasc Moorepark, Cork University Hospital and Alimentary Health Ltd. The APC is investigating mechanisms by which intestinal bacteria influence health and disease and is developing new therapies for lifelong debilitating gastrointestinal diseases such as gastroenteritis, ulcerative colitis and Crohn's disease. For information please visit http://apc.ucc.ie/.

About Align

Align is a daily probiotic supplement that helps build and maintain a strong and healthy digestive system.* Align works by providing a natural defense against episodic digestive upsets such as constipation, diarrhea, abdominal discomfort, urgency, gas and bloating. Align is the only probiotic supplement containing Bifantis (Bifidobacterium infantis 35624). Please visit AlignGI.com for more information.


    *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.


    Contacts:

    Bob Mathias                Barry Kiely           Shirley Johnson

    Alimentary Health          Alimentary Health     Manning, Selvage & Lee

    Phone 1 480 248 7278       +353 21 429 9104      (212) 468-3292

    Email        

bmathias@ahealth.ie bkiely@ahealth.ie shirley.johnson@mslpr.com

CONTACT: Bob Mathias, +1-480-248-7278, , or BarryKiely, +353-21-429-9104, , both of Alimentary Health; orShirley Johnson for Alimentary Health, +1-212-468-3292, bmathias@ahealth.ie bkiely@ahealth.ie shirley.johnson@mslpr.com

Web site: http://www.alimentaryhealth.ie/http://apc.ucc.ie/http://www.AlignGI.com/

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Posted: October 2007

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