Scientific Abstract

Proposal No. IBD-0223R
Principal Investigator:  Paul D. Terry, Ph.D., MPH (replacement PI) Jack S. Mandel, Ph.D., MPH (original PI)
Applicant Organization:  Emory University (Atlanta, Georgia, U.S.A.)
Project Title:  Melatonin supplementation and ulcerative colitis: a pilot randomized clinical trial
Period of Award:  May 1, 2008 – April 30, 2009

Current treatments for ulcerative colitis are not always effective, and often have serious side effects. Therefore, there is considerable interest in finding alternative treatments for this disease. Physiologic data suggest that melatonin is important in gastrointestinal (GI) tract physiology and health, and data from in vitro studies, animal experiments, and some studies in humans suggest that supplemental melatonin may have an ameliorative effect on colitis. However, experimental data on the ability of melatonin to improve ulcerative colitis in humans are lacking. The long term goal of this proposal is to examine whether melatonin supplementation helps alleviate colitis symptoms. To this end, we plan to conduct a pilot randomized, double-blind, placebo-controlled trial (n = 60) that will obtain preliminary data about the effectiveness of melatonin supplementation as a treatment for ulcerative colitis in adult men and women with mild to moderate flare-up of the disease. The specific aims of the trial are: (i) to estimate the effect of 12 weeks of 5 mg/day supplementation with melatonin on ulcerative colitis remission, (ii) to determine the feasibility of recruiting and retaining a sufficient number of ulcerative colitis patients for a larger, more definitive study, and (iii) to determine whether melatonin supplementation has any adverse side-effects when taken daily for 12 weeks in adults with ulcerative colitis. In this novel pilot study, we will – for the first time – provide knowledge of the effects of melatonin supplementation in ulcerative colitis patients, and lay the groundwork for a larger, more definitive trial.