Melatonin and Ulcerative Colitis: A Pilot Clinical Trial
Status:
Terminated
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
Ulcerative colitis is an inflammatory bowel disease that afflicts up to one million people in
the U.S. Symptoms include rectal urgency, bloody diarrhea, moderate to severe abdominal pain,
fever, and fatigue. 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.
The "Melatonin and Ulcerative Colitis" study funded by a grant from the Broad Foundation's
Broad Medical Research Program (http://www.broadmedical.org).