A Randomized Crossover Trial of Bright Light Therapy in Irritable Bowel Syndrome (NCT06676488) | Clinical Trial Compass
CompletedNot Applicable
A Randomized Crossover Trial of Bright Light Therapy in Irritable Bowel Syndrome
United States5 participantsStarted 2025-06-11
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria
* 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
What they're measuring
1
Aim 1a
Timeframe: 2 weeks of morning Bright Light Therapy (BLT)
2
Aim 1b
Timeframe: 2 weeks of morning Bright Light Therapy (BLT)