A Randomized Crossover Trial of Bright Light Therapy in Irritable Bowel Syndrome

Completed · Not applicable · Has a placebo group

Conditions studied: Irritable Bowel Syndrome (IBS), Circadian Misalignment

In brief

The purpose of this research study is to assess whether morning bright light therapy (BLT) using a wearable device called a Re-Timer could potentially improve Irritable Bowel Syndrome (IBS) symptoms and decrease intestinal permeability (leaky gut). Morning bright light therapy will be administrated through a safe-wearable glasses device called a Re-Timer. The Re-Timer glasses are lightweight and deliver blue-green light at 500nm, mimicking exposure to natural light.

Key facts

Study ID

NCT06676488

Run by

Medical University of South Carolina

People needed

5

Starts

2025-06-11

Expected to finish

2026-03-31

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-65 years old
• Irritable Bowel Syndrome based on Rome IV diagnostic criteria
• Mild to severe IBS symptom severity based on IBS-SSS greater than or equal to 75 17.
• Late chronotype based on the Munich Chronotype Questionnaire (Corrected Midpoint of Sleep > 4:00h) 18 Exclusion Criteria
• Subject that are pregnant or plan to become pregnant.
• Night shift workers or people who have crossed more than 2 time zones in the previous 4 weeks.
• Regular use of medications that affect intestinal permeability, and/or endogenous melatonin including metoclopramide, NSAIDs, beta blockers, antibiotics, psychotropic medications, hypnotics and exogenous melatonin products during 4 weeks prior to the study.
• Any major organ disease - known renal impairment, diabetes, liver disease, or significant cardiac failure (NY classification stage III/IV), inflammatory bowel disease or celiac disease per chart review and/or medical history.
• Diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screening.
• Moderate to severe depression (score ≥ 21 or any endorsement of suicidal intent on the Beck Depression Inventory) 19
• Sleep apnea (score high risk in 2 or more categories of the Berlin Questionnaire) 20
• Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale) 21
• Inability or unwillingness of subject to sign an informed consent

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.