ORLANDO, Fla., May 20 -- 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 (Nasdaq: BBAL) reported today. The report by Israeli physicians, was presented on Tuesday at Digestive Disease Week in Orlando, Florida. The strain of E. coli, ATCC20226, (PROBACTRIX(TM)) 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. BioBalance intends to comply with United States Food and Drug Administration requirements for the eventual introduction of PROBACTRIX(TM) to the United States market as a medical food.
Six of the eight IBD patients who completed four to six week PROBACTRIXTM therapy underwent a follow-up capsule endoscopy (CE). The CE studies were initially read in a non-blinded fashion by two experienced capsule endoscopists. 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, CE revealed significant inflammation in the proximal small bowel pre-treatment and significant improvement post-treatment, according to 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, investigator of the pilot trial and coauthor 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."
Eight patients with IBD symptoms and a negative GI evaluation underwent capsule endoscopy (CE) which revealed inflammatory changes mostly in the proximal small bowel. Each of these patients received 20 to 40 cc's PO BID of E-Coli ATCC20226 containing 10 to the seventh live bacteria per cc. (PROBACTRIXTM, The BioBalance Corp) for four to six weeks. Two patients discontinued this Probiotic agent after 10 to 14 days and were placed on alternative preparations.
The remaining 6 patients underwent a follow-up capsule endoscopy after completing a 4 to 6 week course of the Probiotic agent regardless of the clinical response. The report, entitled "The probiotic agent E. coli strain ATCC20226 has a healing effect on proximal inflammation of the small bowel," was coauthored by Dr. Samuel N Adler, Chief of Gastroentorology at Bikur Cholim Hospital in Jerusalem and his colleagues.
Background on IBD
IBD refers to two specific types of disease: Crohn's Disease and ulcerative colitis. Both of these diseases have different forms and are estimated to afflict more than one million Americans. Crohn's disease and ulcerative colitis are chronic digestive disorders. Their cause is unknown. Ulcerative colitis inflames the inner lining of the colon (large intestine) and the rectum. Crohn's disease may affect the lower part of the small intestine, the colon, and other parts of the digestive tract.
The BioBalance Corporation
BioBalance is a development stage company, whose business is the discovery, manufacturing and marketing of probiotic agents and ethical drugs for therapy of gastrointestinal (GI) diseases. The science of probiotics is the utilization of live microbial agents to benefit an animal or human host by improving intestinal microbial balance through the stimulation of the growth of healthy bacteria and thereby restoring the microbial balance. On January 2, 2003, The BioBalance Corp., in a Stock Exchange Agreement, merged with New York Health Care, Inc. ("NYHC"), a publicly traded company engaged in providing home health care services.
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