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NEW YORK -- The BioBalance Corp., a wholly owned subsidiary of New York Health Care, today released the results of a randomized clinical study in which a formulation containing its proprietary biotherapeutic agent, Probactrix, appeared to rapidly and effectively control diarrhea commonly associated with antibiotic usage, known as antibiotic-associated diarrhea (AAD).
Dennis O'Donnell, BioBalance's chief operating officer stated, "based on the results of this study, The BioBalance Corporation plans to explore OTC regulatory approval for this new indication. This represents another opportunity to address a very large market with significant unmet needs utilizing our core technology."
Clinical trials were performed on 80 patients undergoing combination antibiotic therapy (including ampicillin) for acute pneumonia or prostatitis, with 40 patients in the Probactrix treatment group and an equal number in the control group. Professor A. Vertkine, MD, PhD, head of clinical pharmacology and internal medicine at Moscow State Medical University, conducted the trial in two Moscow municipal hospitals.
Results showed that the product significantly reduced gastrointestinal complaints versus the control group (p<0.05) within five days after initiation of Probactrix. In the treatment arm, there was significant improvement noted in relief of average duration of diarrhea symptoms, as measured by stool frequency, at almost half the duration of the control group. After ten days of treatment, the treatment group showed 90 percent complete recovery versus 58 percent for the control group.
The treatment group also showed a measurable improvement in intestinal microflora composition versus the control. Importantly, the treatment group showed a total elimination of Candida albicans in the feces versus the control group, of which 43 percent tested positive. Candida is a pathogenic yeast that is resistant to most antibiotics and can prosper when the intestinal microbial balance is disturbed by antibiotic therapy.
Robert Hoerr, MD, PhD, director of medical and regulatory affairs at BioBalance, added: "This trial is consistent with the results of other Probactrix clinical studies that support the importance of restoring the intestinal microbial balance in relieving diarrhea and other GI symptoms."
According to the Centers for Disease Control and Prevention (CDC), there are 150 million antibiotic prescriptions written annually in the U.S., with the incidence of diarrhea estimated at 20 percent of patients taking antibiotics. Antibiotic treatment destroys the normal intestinal microflora, often resulting in diarrhea and overgrowth of opportunistic pathogens. Antibiotics can also affect the rate of digestion and the metabolism of fatty acids, both of which also contribute to AAD. About 10 to 20 percent of antibiotic diarrhea can lead to a more serious, life threatening form of AAD called pseudomembranous colitis, which can be traced to a bacterium called C. difficile. Diarrhea from antibiotics is particularly problematic in children due to their smaller body mass, which can lead to dehydration and electrolyte imbalance.
BioBalance is a development stage specialty pharmaceutical company focused on the discovery, development and commercialization of proprietary treatments for gastrointestinal disorders.
Source: The BioBalance Corporation