The goal of this open label, phase II clinical trial is to test the efficacy of topical (rectal) administration of the imidazole antifungal agent clotrimazole (CLT) in the treatment of distal intestinal inflammation. Total colectomy with ileal pouch-anal anastamosis (IPAA) has become the treatment of choice for the management of severe ulcerative colitis and familial polyposis coli. Acute and chronic inflammation of the ileal reservoir (clinically referred to as pouchitis) is the most common long-term complication of IPAA, with 15% of patients requiring chronic systemic anti-inflammatory or antibiotic therapy and 2% progressing to a need for pouch excision and revision to ileostomy. The etiology of pouchitis is unknown, and neither fecal stasis, mucosal ischemia, type or size of pouch, age, or gender explain the disease. Treatment has been largely empiric. While metronidazole has been used successfully in most patients, its mechanism of action remains unknown. In addition, a small (Phase I) sample of healthy control subjects will be included to measure the pharamcokinetics of rectal CLT dosing. The development of simple, safe, and effective topical therapies to treat intestinal inflammation could represent a significant clinical advancement in the management of a diverse body of idiopathic, infectious, and allergic intestinal disease states.
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