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

NCT ID NCT07737665

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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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)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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