Melatonin to Improve Sleep Quality in Adults with IBD in Remission A Randomized Double-Blind Placebo-Controlled Trial

What this Trial Is About

Researchers are evaluating the potential benefits of melatonin supplementation on sleep quality in patients with inflammatory bowel disease IBD who are in clinical remission. IBD, including Crohns disease and ulcerative colitis, involves chronic inflammation of the digestive tract and often leads to sleep disturbances, which are linked to worse disease outcomes and quality of life. This study aims to assess whether melatonin, a hormone that regulates sleep and has anti-inflammatory properties, can improve sleep quality in this patient group. Participants are randomly assigned to receive either 2 mg of prolonged-release melatonin or a matching placebo once daily, taken one hour before bedtime. After six weeks, sleep quality is assessed, and if no improvement is observed, the dose is increased to two tablets daily until the study ends at twelve weeks. Follow-up visits occur at six and twelve weeks, either in person or via telephone. The study compares melatonin supplementation against placebo to evaluate its effect on sleep quality and related outcomes. During the study, participants complete sleep quality assessments using the Pittsburgh Sleep Quality Index PSQI at six and twelve weeks, along with the Inflammatory Bowel Disease Questionnaire IBDQ to evaluate quality of life. Researchers monitor changes in sleep quality scores and other related measures to determine the impact of melatonin. Safety and adherence are tracked throughout the trial, which is expected to conclude in April 2027, with primary outcomes assessed at twelve weeks.

Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission