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

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Nov 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a special type of morning light therapy can help improve symptoms for people with Irritable Bowel Syndrome (IBS). The therapy uses a pair of lightweight glasses called Re-Timer that provide a blue-green light, similar to natural sunlight. Researchers want to see if this therapy can reduce symptoms of IBS and decrease a condition known as "leaky gut," which can affect how the intestines function.

To participate in this study, individuals need to be between 18 and 65 years old and diagnosed with IBS based on specific criteria. They should have moderate to severe IBS symptoms and have a sleep pattern that is considered "late chronotype," meaning they tend to stay up late and wake up later in the day. Participants will wear the Re-Timer glasses in the morning and monitor how their symptoms change over time. It’s important to note that certain health conditions and medications may prevent someone from joining the study, so interested individuals should discuss their eligibility with the research team.

Gender

ALL

Eligibility 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