Recent studies indicate that 4 Aminosalicylic Acid (4-ASA) is effective in inflammatory bowel disease. Therapeutic intraluminal concentrations of this drug may be achieved by oral administration of 6 gms per diem of uncoated 4-ASA. To test the therapeutic efficacy and safety of orally administered 4-ASA in symptomatic small bowel Crohn's disease patients, a three month double- blind, placebo-controlled trial at six centers is proposed. The PI is at the university of Vermont and all protocols have originated from the University of Vermont. Crohn's disease will be defined by clinical radiologic, endoscopic, surgical and histologic criteria. Persons with infections or ulcerative colitis, hepatic or renal disease, pregnancy or Crohn's disease activity index (CDAI) of > 450 will be excluded. Disease activity will be judged by the CDAI scoring system with a CDAI of > 150 necessary for entry into the study. The plan was to continue enrollment to attempt to obtain a total of eighty patients. However, recruitment has been extremely difficult and presently only 28 patients have been able to be accrued in the six centers. Therefore, at the advice of the FDA, the grant will most likely be withdrawn by April of 1998.
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