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

NCT06676488 | Recruiting

• 2 other identifiers: Pro00138575P30DK123704
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome (IBS); Circadian Misalignment

Keywords

Stomach; Irritable Bowel Syndrome; Circadian Misalignment

Outcome Measures

Primary Outcomes (2)

• Aim 1a

  In Aim 1a, we predict 2 weeks of morning BLT in IBS subjects with CM will improve IBS-symptom severity based on the IBS Severity Scoring Scale as compared to the control (wear the Re-Timer™ glasses without light therapy).

  2 weeks of morning Bright Light Therapy (BLT)

• Aim 1b

  In Aim 1b, we predict 2 weeks of morning BLT will improve circadian misalignment as accessed by wrist actigraphy (interdaily stability, intradaily variability, and relative amplitude).

  2 weeks of morning Bright Light Therapy (BLT)

Secondary Outcomes (1)

• Aim 2

  2 weeks of morning Bright Light Therapy (BLT)

Study Arms (2)

Re-Timer Device (Bright Light Therapy)

EXPERIMENTAL

Morning bright light therapy will be administrated through a safe wearable device called a Re-timer. The Re-Timer glasses are lightweight and deliver blue-green light at 500nm, mimicking exposure to natural light. The device emits light at a higher wavelength than the UV range and has a UV filter for added safety. Subjects will be asked to wear the glasses for one hour each morning per day for 7 days a week. They will wear the device for a total of 14 days to receive the full therapeutic effect. Additionally, subjects will be asked to complete the light therapy the first hour of being awake and remain indoors while using the device. Participants will be informed that they can wear the device freely throughout their home or work environment but should avoid activities that could potentially be harmful (i.e., driving, contact sports, operating heavy machinery).

Device: Re-Timer glasses

Placebo device (non Bright Light Therapy)

PLACEBO COMPARATOR

Subjects will be asked to wear glasses that do not provide Bright Light Therapy for one hour each morning per day for 7 days a week as recommended by the manufacturer. They will wear the device for a total of 14 days to receive the full therapeutic effect. Additionally, subjects will be asked to complete the light therapy the first hour of being awake and remain indoors while using the device. Participants will be informed that they can wear the device freely throughout their home or work environment but should avoid activities that could potentially be harmful (i.e., driving, contact sports, operating heavy machinery).

Device: Placebo Device

Interventions

Re-Timer glasses DEVICE

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

Re-Timer Device (Bright Light Therapy)

Placebo Device DEVICE

Placebo glasses not providing Bright Light Therapy

Placebo device (non Bright Light Therapy)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

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MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Caitlin Green

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keaveny (Katy) Donovan

CONTACT

843-792-7974; donova@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: June 11, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)