A non-pathogenic strain of E. coli probiotic oral suspension appeared to relieve patients of the major clinical symptoms of inflammatory bowel disease (IBD) in a pilot trial, the BioBalance Corporation reported today.
The report by Israeli physicians, was presented on Tuesday at Digestive Disease Week in Orlando, Florida. The strain of E. coli (ATCC20226) called Probactrix is the result of work by BioBalance, a developer of probiotic agents and ethical drugs for therapy of gastrointestinal (GI) diseases.
The strain is a proprietary formulation of M-17 E. coli and is approved as an OTC pharmaceutical in Russia and as a food supplement in Israel, according to BioBalance. It added that it intends to comply with United States Food and Drug Administration requirements for the eventual introduction of Probactrix to the United States market as a medical food.
The report, co-authored by Dr. Samuel N Adler, chief of gastroenterology at Bikur Cholim Hospital in Jerusalem, was presented on Tuesday at Digestive Disease Week in Orlando, Florida.
Six of eight IBD - Crohn's Disease and ulcerative colitis - patients who completed four to six week Probactrix therapy underwent a follow-up capsule endoscopy (CE). The CE studies were initially read in a non-blinded fashion by two experienced capsule endoscopists. The researchers said three out of six patients had a very significant clinical response, with marked reduction in abdominal symptoms and improvement in well being.
In these three patients, the CE revealed significant inflammation in the proximal small bowel pre-treatment and significant improvement post-treatment, according to the researchers.
"This initial study provides compelling evidence that this 'probiotic' approach to treating IBD has significant therapeutic potential, and merits further investigation," said Dr. Samuel N Adler, chief of gastroenterology at Bikur Cholim Hospital in Jerusalem, Israel, investigator of the pilot trial and co-author of the study.
"The study demonstrated endoscopically that this novel Probiotic agent has a healing effect on the small bowel mucosa in some patients with proximal inflammation of the small bowel."