application): The goal of the proposed studies in this proposal is to develop a protease-inhibitor containing product which can be developed commercially as an anti-inflammatory agent for use in IBD. In Phase I of the grant work, it was established that an extract of soybeans containing the protease inhibitor BBIC could be used as an anti-inflammatory agent in an in vivo model of inflammation in which ulcerative colitis (UC) was induced in mice by adding dextran sulfate sodium to the drinking water. In Phase II of the grant work, it will be determined whether BBIC has similar anti-inflammatory effects in an animal model of Crohn's Disease (CD) in which rats are utilized. As part of Phase II of this grant work, a pilot study on the effects of BBIC in UC patients will also be performed. BBIC achieved Investigational New Drug (IND #34671) status from the Food and Drug Administration and human trials to evaluate it as a human cancer chemopreventive agent began in 1992. Proteolytic activity is thought to play a major role in IBD. BBI and BBIC are expected to have major anti-inflammatory effects in patients with UC or CD. It is expected that the results of this human trial will give information about the probability of BBIC having a beneficial effect in the treatment of UC and data to indicate the best biomarkers to utilize in a future Phase II BBIC efficacy trial in patients with IBD.
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