Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission: A Randomized Double-Blind Placebo-Controlled Trial

NCT07737665 | Recruiting Phase 4

• 1 other identifier: SI 243/2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IBD (Inflammatory Bowel Disease)

Keywords

inflammatory bowel disease; melatonin; sleep quality; Pittsburgh Sleep Quality Index; quality of life; fecal calprotectin

Outcome Measures

Primary Outcomes (1)

• PSQI (Pittsburgh Sleep Quality Index) score at 12th week of study

  Comparison of sleep quality between the melatonin and placebo groups in patients with IBD in clinical remission

  12 weeks

Secondary Outcomes (3)

• PSQI (Pittsburgh Sleep Quality Index) score at 6th week of study

  6 weeks

• Component of PSQI score

  12 weeks

• Quality of life

  6-12 weeks

Study Arms (2)

Melatonin

EXPERIMENTAL

Participants were randomized into two groups to receive either 2 mg of prolonged release melatonin or placebo, which were manufactured to be identical in appearance. The study medication was prescribed at a dose of one tablet daily, taken one hour before the participant's usual bedtime. Participants were scheduled for follow-up at 6 and 12 weeks after initiation of the study medication, either at the IBD clinic or via telephone contact. At the 6-week follow-up, sleep quality was assessed using PSQI. If the PSQI score decreased from baseline, participants continued the study medication at the same dose until the end of the study. If the PSQI score remained unchanged or increased, the dose of the study medication was escalated to two tablets per day and continued at that dose until study completion.

Drug: Melatonin ("Circadin")

Placebo

PLACEBO COMPARATOR

placebo were manufactured to be identical in appearance

Drug: Placebo

Interventions

Melatonin ("Circadin") DRUG

2 mg of prolonged release melatonin was prescribed at a dose of one tablet daily, taken one hour before the participant's usual bedtime.

Melatonin

Placebo DRUG

placebo were manufactured to be identical in appearance

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

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

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Sleep Initiation and Maintenance Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Julajak Limsrivilai, MD

  Faculty of Medicine Siriraj Hospital, Mahisol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julajak Limsrivilai, MD

CONTACT

+66814968895; alimsrivilai@gmail.com

Ekawat Manomaiwong, MD

CONTACT

+66876818221; e_manomaiwong@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Julajak Limsrivilai, M.D.

Model Details: This randomized, double-blind, placebo-controlled trial enrolled IBD patients in clinical remission with a Pittsburgh Sleep Quality Index (PSQI) score \> 5. Participants were randomized (1:1) to receive either 2 mg of prolonged-release melatonin or a placebo daily for 12 weeks. The primary outcome was sleep quality at week 12 assessed by the PSQI. Secondary outcomes included PSQI scores at week 6, individual PSQI components, quality of life (IBDQ), and inflammatory markers (CRP and fecal calprotectin).

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TH (1)