Octreotide is a drug that reduces the effects of many hormones. It is FDA approved for the treatment of acromegaly, a disease in which patients have too much growth hormone, where it acts by decreasing blood levels of growth hormone. It is also widely used for the symptomatic treatment of diarrhea where it acts by decreasing hormones that cause fluid secretion by the intestine. It also has anti-inflammatory effects and there is evidence that octreotide decreases diarrhea by slowing intestinal transit. In summary, octreotide has inhibitory effects on many gastrointestinal peptide hormones. It may act in several ways to improve symptoms in Crohn's disease including decreasing intestinal secretion, decreasing inflammation, and decreasing intestinal transit. The purpose of this trial is to see whether octreotide, given by subcutaneous injection (SQ), is better than placebo (sugar water) in improving the symptoms and quality of life in patients with Crohn's disease. Fifteen patients with moderately severe active Crohn's disease will be randomly assigned to receive low dose octreotide, high dose octreotide, or placebo (five per group). Patients will be evaluated during a screening phase where informed consent will be obtained and eligibility will be determined. Patients will undergo a pre-treatment endoscopic procedure and then will be randomized to receive octreotide or placebo. The patients will be treated with the study drug for eight weeks and then undergo a post-treatment endoscopic procedure. Validated survey instruments of clinical response (Crohn's Disease Activity Index - CDAI) and quality of life (Inflammatory Bowel Disease Questionnaire - IBDQ) will be administered before treatment, immediately post treatment and eight weeks after therapy is concluded. The primary clinical endpoint will be clinical response as defined as 100 point decrease in CDAI. Other endpoints include: clinical remission defined as CDAI < 150; improved quality of life as defined as increase in IBDQ 170; reduction in corticosteroid use; improvement in endoscopic appearance as measured by Crohn's Disease Endoscopic Index of Severity; and improvement in histology.

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University of Michigan Ann Arbor
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