Using bright light therapy to improve symptoms of irritable bowel syndrome
A Randomized Crossover Trial of Bright Light Therapy in Irritable Bowel Syndrome
This study is testing whether using bright light therapy with special glasses can help people with irritable bowel syndrome feel better and improve their gut health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06676488 on ClinicalTrials.gov |
What this trial studies
This research assesses the effects of morning bright light therapy (BLT) using Re-Timer glasses on patients with irritable bowel syndrome (IBS) and circadian misalignment. The study involves a randomized crossover design where participants will receive either the BLT or a placebo for two weeks, followed by a washout period and then the alternate treatment. The primary focus is to evaluate changes in IBS symptom severity, intestinal permeability, and stool microbial diversity. A total of 30 subjects with active IBS symptoms will be enrolled in this pilot trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of IBS and late chronotype.
Not a fit: Patients who are pregnant, night shift workers, or have certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly alleviate IBS symptoms and improve gut health for patients.
How similar studies have performed: While the approach is innovative, similar studies exploring light therapy for various conditions have shown promising results, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Caitlin Green — Medical University of South Carolina
- Study coordinator: Keaveny (Katy) Donovan
- Email: donova@musc.edu
- Phone: 843-792-7974
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.