Melatonin and Ulcerative Colitis: A Pilot Clinical Trial

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Age 18-69 years.

• Diagnosed with ulcerative colitis and currently experiencing a flare up of mild-moderate severity according to Mayo Scoring system (>=4 and <=10).

• Has a regular GI physician(s).

• Availability for 14 weeks after enrolling in the study.

• Female patients of child bearing potential must be surgically sterile or have a negative urine pregnancy test and practice acceptable contraception (i.e., abstinence, oral, intramuscular, or implanted hormonal contraception, 2-barrier methods such as condom, diaphragm or spermicide).

Exclusion Criteria:

• Night shift workers; otherwise, inability to attend morning study visits.

• Current severe colitis according to the Mayo Scoring System (>10) or requiring hospital admission, or current very mild colitis (<4).

• Current supplemental intake of melatonin or currently using tobacco products.

• Proctitis or Crohn's disease

• Previous gastrectomy or small or large bowel resection

• Malabsorption syndrome (e.g., pancreatic insufficiency).

• History of large bowel resection for any reason.

• Diagnosed narcotic or alcohol dependence.

• On renal dialysis.

• Active liver disease (a chronic condition or under current therapy)

• Seizure disorders

• Immune system disorders

• Any history of hypo- or hyperparathyroidism.

• Unable to be off aspirin for 7 days.

• Use of systemic or rectal steroids in the past 8 weeks.

• Have a history of allergy or hypersensitivity to melatonin.

• History of bleeding disorder or current use of anticoagulant medication.

• Current use of calcium channel blockers, anticonvulsants, sedatives, hypnotics, or psychotropic medications.

• Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the following 6 months, or are currently taking hormone replacement therapy (HRT).