RecruitingNot ApplicableNCT06676488

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


Sponsor

Medical University of South Carolina

Enrollment

30 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria9

  • 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

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Interventions

DEVICERe-Timer glasses

Morning bright light therapy (BLT) will be administered through a safe wearable glasses device called a Re-Timer, purchased from the manufacturer Re-Timer.

DEVICEPlacebo Device

Placebo glasses not providing Bright Light Therapy


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06676488


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