VSL#3 Probiotic Now Generally Recognized as Safe (Gras) for the Dietary Management of Irritable Bowel Syndrome (press release)

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New data has shown that VSL#3 provides effective relief in the dietary management of serious intestinal disorders such as ulcerative colitis and pouchitis. Based on recently published research from the Mayo Clinic, an independent panel of qualified experts has determined that VSL#3 is generally recognized as safe (GRAS), under the conditions of intended use as a medical food for the dietary management of irritable bowel syndrome (IBS). VSL#3 probiotic is a preparation of living microbial cells used extensively for the management of gastrointestinal disorders.

Probiotics, because of their potential to help manage GI distress symptoms, are the subject of widespread research. When ingested, probiotics positively influence the composition of the bacterial population in the intestines. Normally, intestinal bacteria act as a protective barrier in the gastrointestinal (GI) tract, but in some situations, the ‘bad’ bacteria outnumber the ‘good’ bacteria. IBS is characterized by abdominal pain or discomfort due to gas (flatulence) and bloating that is associated with a change in bowel pattern (loose or more frequent bowel movements, diarrhea and/or constipation, etc).

“There is evidence that probiotics such as VSL#3 have a role in the management of inflammatory intestinal disorders such as pouchitis, and increasing evidence that they may alleviate some of the symptoms associated with IBS,” said Jay W. Marks, M.D. a board certified internist and gastroenterologist from UCLA/Cedars-Sinai Medical Center. “Recent studies have demonstrated that probiotics, including VSL#3, are safe and have a promising therapeutic benefit for IBS patients.”

VSL#3 works by colonizing the GI tract with probiotic bacteria that adhere to the walls and form a barrier that protects the inner layer of the gut from “bad” bacteria and other substances that cause inflammation. Results of previous research suggest immune function, motility and the intestinal environment are positively influenced by probiotics.

One study looked at the effect of individual bacteria on IBS symptoms, and found probiotics contributed to the production of anti-inflammatory agents, thus reducing inflammation. In addition, probiotic bacteria may also provide relief for patients with functional diarrhea, or IBS with diarrhea, by altering the intestinal environment. Bloated IBS patients (with and without diarrhea) reported experiencing significantly improved bowel control with VSL#3 relative to placebo. Research suggests certain bacteria may influence the secretion of fluids in the colon that contribute to functional diarrhea or IBS with diarrhea. Among all studies, no serious side effects were reported.

According to Dr. Marks, “Patients and their physicians should be aware of the potential of probiotics such as VSL#3 to manage pouchitis and some symptoms of IBS.”

GRAS is an FDA designation that acknowledges certain food additives as safe under the conditions of their intended use by qualified experts. To receive such recognition, the product must establish a consensus of expert opinion regarding the safety of its use based on a review of scientific evidence.

About Sigma-Tau Pharmaceuticals, Inc.

Working to Make Rare Diseases Even Rarer There are some 6,000 identified rare diseases that affect approximately 10 million patients in the United States. The founding principle and core belief of Sigma-Tau Pharmaceuticals, Inc., a wholly owned U.S. subsidiary of Sigma-Tau S.p.A., is that finding therapies for rare diseases is just as important as finding ones for more common diseases. After all, to the patient, there’s nothing “rare” about their condition.

To that end, Sigma-Tau Pharmaceuticals has been focused on rare diseases since its founding, and was one of the first companies to obtain an Orphan Drug Designation in the United State more than 20 years ago.

The Sigma-Tau group is always looking to explore entirely new approaches to treating disease. This is illustrated by the company’s study of the biologic underlying diseases, an alternative approach referred to as “biologic pharmacology.” The research is based on the assumption that disease begins at the metabolic level, when the biochemical pathways within cells and communication among them are altered.

Source: Chamberlain Communications Group

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