Review of probiotic trial research finds only Bifantis able to claim efficacy for IBS symptoms

Study adds to growing evidence of B. infantis 35624 efficacy in IBS population

CINCINNATI – March 23, 2009 – A review by researchers at Northwestern University (Chicago, IL.) and University of Michigan (Ann Arbor, MI) of the utility of probiotics in the treatment of Irritable Bowel Syndrome (IBS) found that Bifidobacterium infantis 35624 was the only probiotic strain out of 13 different individual strains or preparations reviewed to significantly improve symptoms of IBS, including abdominal pain, bloating and bowel movement difficulty. Bifidobacterium infantis 35624 is marketed as Bifantis® and can be found in a daily probiotic supplement by Procter & Gamble. The researchers reviewed 16 random-controlled-studies, evaluating the efficacy, safety and tolerability of probiotics in the treatment of IBS. With the exception of the Bifidobacterium infantis 35624 studies, researchers found the other trials did not use an appropriate study design and did not adequately report adverse events. The article was published on the American Journal of Gastroenterology website in advance of appearing in the publication's April 2009 issue¹.

Irritable Bowel Syndrome affects one in five Americans and treatment options are limited. Darren. M Brenner, Division of Gastroenterology and Department of Internal Medicine, at Northwestern University and lead investigator of this study, hypothesized that alterations in gut microflora may contribute to the development of IBS symptoms, and believed these symptoms could be improved by probiotics. "Probiotics are gaining popularity for the treatment of multiple gastrointestinal disorders, including IBS," said Brenner, MD. "After assessment of the methodological and statistical designs of these studies, B. infantis 35624 was the only probiotic that showed repeated efficacy."

Clinical evidence and support for Bifantis continues to grow

Bifidobacterium infantis 35624, discovered in the early 1990s by microbiologists at Alimentary Health in Cork, Ireland in partnership with P&G, has been independently tested and evaluated in several clinical trials conducted with humans. This latest review provides continued clinical evidence of Bifantis efficacy in helping to manage a range of gastrointestinal issues including abdominal pain, bloating, constipation, diarrhea, gas and urgency. Bifantis efficacy data has been published or referenced in several medical journals, including the American Journal of Gastroenterology² , Gastroenterology³ , New England Journal of Medicine⁴ , Public Library of Science ( PLoS)⁵ and Nutrition in Clinical Practice⁶. Bifantis is found in the number one gastroenterologist recommended probiotic supplement in the United States⁷ .

Susan Abeln, Principal Scientist at Procter & Gamble said, "P&G has worked with Alimentary Health to study and develop a supplement with Bifantis because we firmly believe in the benefits of this strain for the millions of Americans struggling to manage digestive upsets each day. We're excited to make Bifantis available to consumers nationwide this spring."

Further credentialing the probiotic strain, P&G recently announced that Bifantis meets the probiotic guidelines established by The International Scientific Association for Probiotics and Prebiotics (ISAPP). These guidelines include five key criteria that consumers should consider when selecting a probiotic product - strain specificity, clinical proof, packaging, and the quality and quantity of probiotics in a product. Bifantis is proven to fully meet these guidelines, making it a good option for those who want to build and maintain a natural defense against abdominal discomfort and episodic digestive upsets such as constipation, diarrhea, urgency, gas and bloating.

April is National IBS Awareness Month

April is IBS Awareness Month, making this probiotic review timely and appropriate for all IBS sufferers in need of relief. IBS is one of the most common functional bowel disorders diagnosed by primary care physicians and gastroenterologists; and 70 percent of IBS sufferers do not seek medical treatment and continue to suffer from digestive upsets. IBS is second only to the common cold as a leading cause of workplace absenteeism in the U.S. IBS costs the U.S. healthcare system up to an estimated $20 to 25 billion annually in direct and indirect costs⁸.

About Bifantis

Bifantis ( Bifidobacterium infantis 35624) is a probiotic strain that can help strengthen the body's natural defenses and play an important role in basic digestion, proper metabolism and overall well-being. Bifantis is the only natural probiotic strain found in Align. Bifantis has clinically demonstrated that, when taken regularly, it can help promote normal digestive health. Capsules containing Bifantis deliver millions of good bacteria to the digestive system to restore intestinal balance and maintain normal digestive health. Visit www.Bifantis.com for more information.

Bifantis was developed by Alimentary Health.

About Procter & Gamble (NYSE:PG)

Three billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Pampers®, Tide®, Ariel®, Always®, Whisper®, Pantene®, Mach3®, Bounty®, Dawn® Pringles®, 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. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.

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.

Contact: Velvet Gogol Bennett, P&G
Phone: (513) 622-4734
Email: gogolbennett.vc@pg.com

Contact: Chido Tsemunhu, MS&L Worldwide
Phone: (212) 468-3681
Email: Chido.Tsemunhu@mslworldwide.com

1. Am J Gastroenterology advance online publication, 10 March 2009; doi: 10.1038/ajg.2009.25

2. Whorwell PJ, Altringer I, Morel J, et al, Efficacy of an Encapsulated Probiotic Bifidobacterium Infantis 35624 in Women with Irritable Bowel Syndrome; Am. J Gastroenterology, 2006:101(7): 1581-1590

3. O'Mahony L, McCarthy J, Kelly P, et al, Lactobacillus and Bifidobacterium in Irritable Bowel Syndrome: Symptom Responses and Relationships to Cytokine Profiles, Gastroenterology, 2005;128 (3): 541-551

4. E. A. Mayer, M.D., Irritable Bowel Syndrome; N Engl J Med 2008;358;1692-9

5. O'Mahony C, Scully P, O'Mahony D, Murphy S, O'Brien F, et al. (2008) Commensal-Induced Regulatory T Cells Mediate Protection against Pathogen-Stimulated NF-kB Activation. PLoS Pathog 4(8): e1000112. doi:10.1371/journal.ppat.1000112

6. Arnold Wald and David Rakel; Behavioral and Complementary Approaches for the Treatment of Irritable Bowel Syndrome; Nutrition In Clinical Practice; 2008:23 (3): 284 - 292

7. Among those who recommended a brand of probiotic in 2008, Wolters Kulwer survey, 2008

8. LadabaumU. Irritable Bowel Syndrome. Adv Stud Med 2004; 4(3):128-134; Drossman DA, Camilleri M, Mayer EA, Whitehead WE. AGA Technical Review of Irritable Bowel Syndrome. Gastroenterolgy 2002;123:2108-2131; Johns Hopkins Resource Center, Digestive Diseases Library. Monograph on Irritable Bowel Syndrome (2004). www.hopkins-gi.org