Lay Summary

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

Melatonin is a hormone that is associated with sleep and other body functions that may be related to health.  Melatonin is produced in the pineal gland and, in fact, it is produced in even greater amounts in the gut.  Melatonin appears to be important in gastrointestinal tract physiology and health, and data from cell and animal experiments, and some studies in humans, suggest that supplemental melatonin may help ameliorate colitis.  Given that current treatments for ulcerative colitis are not always effective, and often have serious side effects, there is considerable interest in finding alternative treatments for this disease.  However, experimental data on the ability of melatonin to improve ulcerative colitis in humans are lacking.  To address this, we plan to conduct a pilot clinical trial (60 adult male and female participants) that will obtain preliminary data about the effectiveness of melatonin supplementation as a treatment for ulcerative colitis in adult men and women with the disease.