Ulcerative Colitis

The cause of pouchitis is not known, though it is believed to result from an immune response to pathogenic bacteria in the pouch flora.

There are no currently approved treatments for pouchitis.

Current management involves short-term and occasionally chronic treatment with antibiotics.

The phase I/II, randomized, placebo-controlled, multi-center study will be conducted in approximately 63 antibiotic-dependent pouchitis patients to demonstrate the ability of a prescription formulation of Probactrix to maintain symptomatic response of pouchitis symptoms after antibiotic withdrawal.

The principal investigators of the trial are Darrell S.

Pardi, MD, and William J.

Sandborn, MD, of the Division of Gastroenterology at the Mayo Clinic in Rochester, Minnesota.

"FDA approval of this clinical trial represents a major milestone for the company," said Dennis O'Donnell, BioBalance's President & CEO.

"We continue to make tremendous strides in advancing the science behind Probactrix and validating the extensive overseas clinical history of this product." Probactrix is a patented, single strain of non-pathogenic E.coli M-17 that was originally isolated from the intestinal microflora of a healthy ...

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