Pouchitis is a debilitating gastrointestinal disorder that can develop following corrective surgical treatment of ulcerative colitis. There are no currently approved treatments for pouchitis and management of the disease involves short-term and occasionally chronic treatment with antibiotics.
The phase I/II 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 compared to placebo.
Probactrix is a patented, single strain of non-pathogenic E.coli M-17 that was originally isolated from the intestinal microflora of a healthy volunteer. One mechanism of action is believed to work by selective displacement of pathogenic bacteria in the digestive tract and preventing their re-colonization, restoring a healthy balance of intestinal flora without the potential negative consequences of antibiotic use.
The active ingredient in Probactrix has a long history of use for a variety of gastrointestinal conditions, which has been well documented in foreign studies. “We continue to make tremendous strides in advancing the science behind Probactrix and validating the extensive overseas clinical history of this product,” said Dennis O’Donnell, BioBalance’s president & CEO.