NCT07737665
Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission
Recruiting · Phase 4 · Mahidol University · registry updated 2026-08-04
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
Sleep disturbances are common in patients with inflammatory bowel disease (IBD) and are associated with increased disease activity and reduced quality of life. Melatonin, a hormone regulating circadian rhythms, has shown potential anti-inflammatory and sleep-promoting effects in preliminary studies. This study aimed to evaluate the efficacy of melatonin supplementation on sleep quality in IBD patients in clinical remission.
Inclusion
- 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
- 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