Sleep hormone melatonin put to the test for IBD patients with poor sleep

NCT ID NCT07737665

Recruiting now Symptom relief Sponsor: Mahidol University Source: ClinicalTrials.gov ↗

First seen Jul 30, 2026 · Last updated Aug 05, 2026 · Updated 3 times

Summary

This phase 4 trial tests whether taking a 2 mg prolonged-release melatonin tablet before bed can improve sleep quality in adults with inflammatory bowel disease (Crohn's disease or ulcerative colitis) whose disease is in remission. Participants must have poor sleep (PSQI score >5) and will be randomly assigned to receive melatonin or a matching placebo for 12 weeks. The study measures sleep quality using the Pittsburgh Sleep Quality Index at 6 and 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: melatonin (prolonged-release 2 mg tablet taken one hour before bedtime)
What this could lead to: If it works, this could offer a simple, low-cost way to improve sleep and quality of life for people with IBD.
What could go wrong: This is a small, early-phase trial, and melatonin may not improve sleep more than a placebo. Side effects like drowsiness or headache are possible.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease insomnia ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IBD (INFLAMMATORY BOWEL DISEASE)

Contacts and locations

Locations

Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University 2 Wang Lang Rd
RECRUITING

Bangkok Noi, Bangkok, 10700, Thailand

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