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New Study Shows Probiotic Strain Effective in Improving Irritable Bowel Syndrome Symptoms
Date:3/24/2009

Bacillus coagulans significantly reduces abdominal pain and bloating

CLEVELAND, March 24 /PRNewswire/ -- A new study published in the March issue of Postgraduate Medicine found that a strain of probiotic bacteria, Bacillus coagulans GBI-30, PTA-6086 was effective in relieving abdominal pain and bloating in subjects with irritable bowel syndrome (IBS). As many as 25 percent of the U.S. population suffer from IBS, a condition characterized by a number of uncomfortable digestive symptoms and associated with a severe reduction in quality of life. Although there are two prescription drugs for IBS, doctors are limited as to the solutions they can recommend. The new study adds to the growing body of evidence that certain probiotics can help with IBS and provides hope for IBS sufferers of a new option.

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The study found that subjects taking the Bacillus coagulans probiotic strain, trademarked GanedenBC30 and marketed in the over-the-counter product, Digestive Advantage Irritable Bowel Syndrome, experienced statistically significant reductions in abdominal pain and bloating versus baseline at each of the weekly measurements taken throughout the 8-week study. Subjects taking placebo experienced statistically significant reductions in just two of the weekly abdominal pain measurements and saw no statistically significant effect in bloating. "This study helps confirm that Bacillus coagulans is effective in IBS," said Larysa Hun, M.D., author of the 44 subject study. "A combination of Bacillus coagulans, Lactobacillus acidophilus, and Streptococcus thermophilus was previously shown in a clinical trial to significantly improve IBS symptoms, but it was not possible to determine what effect, if any, each strain had by itself."

IBS is associated with impaired quality of life, psychiatric problems, family disruption, impaired workplace performance, unnecessary tests and surgery, high direct and indirect costs, and even death due to IBS medications or interventions. "IBS is the most common functional gastrointestinal disorder (FGID) and represents a tremendous public health problem," noted Nicholas Talley, M.D., Ph.D., of the Mayo Clinic, an expert on IBS and author of a scientific review article about the impact FGIDs have on society.

Two drugs, alosetron and lubiprostone, are FDA-approved only for certain types of IBS: alosetron is for women with severe IBS-related diarrhea only and has serious potential side effects; lubiprostone is only for women with IBS-related constipation. Doctors commonly recommend over-the-counter medications such as laxatives, antidiarrheals, and bulking agents for IBS. But in a recent interview, Talley said, "they don't work well for most people with IBS."

"We know from consumer data that people who try Digestive Advantage Irritable Bowel Syndrome are more likely to become repeat purchasers of the product than people who try 30 other of the most popular brands of digestive products sold in stores," said Marshall Fong, vice president of marketing at Ganeden Biotech, which helped fund the study through a research grant. "This study and our other IBS studies provide scientific data to support what hundreds of thousands of satisfied consumers already tell us with their strong loyalty to our products."

The study adds to the growing amount of evidence suggesting that some probiotics are effective in relieving various IBS symptoms. Some experts would like to see continued research even if they already recommend probiotics to their patients. Maurizio Fava, M.D., a professor and researcher at Harvard and Massachusetts General Hospital, is beginning a placebo-controlled clinical trial to evaluate the efficacy of Ganeden's probiotic in patients with IBS and depression to test the hypothesis that there are common underlying factors beneath the two conditions that may be impacted by taking the Bacillus coagulans strain of probiotics. In describing a pragmatic approach to probiotics and IBS, Fava said, "While more placebo-controlled studies are necessary to determine whether giving probiotics to large populations of people, such as those with IBS, delivers a better benefit-to-cost or benefit-to-risk than doing nothing or resorting to other alternatives, it doesn't mean that individuals shouldn't take them if their doctor recommends them and they provide relief."

About Ganeden Biotech

Founded in 1996, Ganeden Biotech Inc. is a private company based in Cleveland, Ohio, and is the largest seller of over-the-counter probiotics in the U.S. through its Digestive Advantage and Sustenex brands. It also licenses its patented probiotic bacteria, GanedenBC30, for use in commercial food and beverage applications as well as in medical foods and dietary supplements. GanedenBC30 was found to be Generally Recognized As Safe (GRAS) by an independent expert panel assembled to assess its safety in use as a food ingredient. Digestive Advantage and Sustenex are available at over 40,000 retailers nationwide including Walmart, CVS/pharmacy, Walgreens, Rite-Aid, Stop & Shop, Giant, Publix, Kroger, and Target. For more information, visit www.digestiveadvantage.com, www.sustenex.com, or www.ganedenlabs.com.


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