Melatonin to improve sleep quality in adults with inflammatory bowel disease in remission
Official title: Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission: A Randomized Double-Blind Placebo-Controlled Trial
Run by Mahidol University · NCT07737665 · Data updated 2026-11-12
This study tests whether melatonin can improve sleep quality in adults with IBD who are in clinical remission.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Bangkok Noi, Bangkok) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | April 1, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | August 4, 2026 |
| Trial ID | NCT07737665 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with Crohn's disease or ulcerative colitis in clinical remission, who have poor sleep quality (PSQI > 5) and meet all inclusion criteria.
✕Probably not a fit
Patients with no improvement in sleep quality or with adverse effects may not experience benefits from melatonin.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
ThisPhase 4 interventional study evaluates melatonin versus placebo for improving sleep quality in adults with inflammatory bowel disease who are in clinical remission. Eligible participants have Crohn's disease or ulcerative colitis with low disease activity, a PSQI greater than 5, and no recent changes in medications. Participants will receive either melatonin or placebo in a controlled setting, with sleep quality as a primary outcome and safety monitored throughout. The trial builds on prior data suggesting sleep disturbances are common in IBD and that melatonin may have sleep-promoting and anti-inflammatory properties. Results could inform whether melatonin is a helpful adjunct for managing sleep problems in this patient population.
Why it matters
Potential benefit: If successful, participants may experience improved sleep quality and overall quality of life.
How similar studies have gone: Previous studies in related areas suggest potential sleep benefits from melatonin, but data in IBD remission populations are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * IBD patients with clinical remission Crohn's disease: HBI \< 5 Ulcerative colitis: Partial Mayo score 0-1 w/o bloody stool * Age \> 18 years * PSQI score \> 5 * No medical adjustment for 2 months and use corticosteroids not more than Prednisolone equivalent 5 mg/day Exclusion Criteria: * Current alcohol or substance abuse * High risk for OSA (STOP-BANG score \> 5) * Psychiatric problem: PHQ-9 score \> 20 or GAD-7 score \> 20 * Hypnotic drug use and unable to hold for 1week before trial * Shift worker
Where it's running
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Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University 2 Wang Lang Rd
Bangkok Noi, Bangkok, Thailand Recruiting
Study contacts
- Principal investigator: Julajak Limsrivilai, MD — Faculty of Medicine Siriraj Hospital, Mahisol University
- Study coordinator: Julajak Limsrivilai, MD
- Email: alimsrivilai@gmail.com
- Phone: +66814968895
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.