News Release

Experts continue to cite Bifantis as promising probiotic treatment for Irritable Bowel Syndrome

Studies show inflammatory biomarkers return to normal levels, reduction in IBS symptoms after treatment with Bifantis

Peer-Reviewed Publication

Manning Selvage & Lee

Cincinnati, OH – July 30, 2007 – Two new review articles that cover therapeutic approaches to irritable bowel syndrome (IBS) in the July issue of Nutrition in Clinical Practice, cite growing evidence that probiotics, and specifically Bifidobacterium infantis 35624 (Bifantis®), are effective in helping manage IBS. Both articles point to data that suggest Bifantis (available in the U.S. only in supplement form, marketed as Align) – has anti-inflammatory properties that help normalize gut function at a cellular level.

In the first article, "Behavioral and Complementary Approaches for the Treatment of IBS," authors note that probiotic and IBS studies are "fraught with inconsistencies" but also note that there is "increasing evidence of efficacy" for probiotics . Two studies on Bifantis are cited. The first study evaluated patients randomly receiving Lactobacillus salivarius, Bifantis or placebo, and after eight weeks found that the patients receiving Bifantis had the greatest reduction in IBS symptoms. The study also found that these patients experienced a reduction of inflammatory cytokines compared with those taking placebo .

The second study cited in the review article established the therapeutic dose for Bifantis in capsule form at 1 × 108 colony forming units as significantly superior to placebo and all other doses for improvement in abdominal pain, bloating, bowel dysfunction, straining, and gas at the end of the four week study .

"We think that imbalances in gut microflora lead to a chronic, low-level inflammation in the intestines and the presence of these inflammatory biomarkers in the bloodstream.

The overall impact of these circulating biomarkers is unclear, but it's been suggested that they could negatively impact healthy tissues," said Liam O'Mahony, the lead investigator of the inflammation study cited in the review article. "The Bifantis results not only have great implications for the treatment of digestive conditions, but offer researchers a potentially new path of exploration around inflammation-based diseases like arthritis."

The second review article, "Update on Irritable Bowel Syndrome and Gender Differences", which cites the same study by O'Mahony et al., notes that the "strain and type of probiotic used may be responsible for the degree and type of improvement."ii The article highlighted efficacy data from the O'Mahony study, noting that the patients receiving Bifantis experienced a reduction of IBS symptoms ranging from constipation, diarrhea and bloating for up to four weeks.

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About IBS

IBS is a gastrointestinal disorder that is characterized by a group of symptoms including constipation, diarrhea, urgency, abdominal discomfort, gas and bloating. A painful and embarrassing condition, IBS affects about 10 – 20 percent of the American population and is most common among women. The cause of IBS is unclear, but can include medication (antibiotics), stress, and dairy.

About Bifantis® and Align®

Bifantis® (Bifidobacterium infantis 35624) is a natural probiotic strain. Clinical trials have demonstrated that regular use of Bifantis helps to build and maintain a strong, healthy digestive system. Capsules of Bifantis deliver millions of good bacteria to work within the digestive system to restore intestinal balance and maintain normal digestive health. For more information, visit www.bifantis.com.

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, an FDA-approved NDI.

Align is sold in boxed blister packs of 28 easy-to-swallow capsules. The 28-day supply retails for approximately $32.99.

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. www.alimentaryhealth.ie

About Procter & Gamble

Three billion times a day, P&G brands touch the lives of people around the world. P&G has one of the strongest portfolios of quality, leadership brands in consumer health and wellness, including Actonel®, Align®, Always®, Asacol®, Crest®, Enablex®, Metamucil®, Oral-B®, Pepto-Bismol®, Prilosec OTC®, Scope®, Tampax®, and Vicks®, in addition to its trusted consumer brands, including Ariel®, Braun®, Bounty®, Charmin®, Dawn®, Downy®, Duracell®, Folgers®, Gillette®, Head & Shoulders®, Iams®, Lenor®, Mach3®, Olay®, Pantene®, Pampers®, Pringles®, Tide®, Wella®, and Whisper®. The P&G community consists of over 135,000 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.


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