A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis

NCT05579392 | Recruiting

• 1 other identifier: 22041302
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Crohn's Disease (CD) and Ulcerative Colitis (UC), collectively known as inflammatory bowel disease (IBD), are two of the most significant chronic conditions of the gastrointestinal tract (GIT) and affects over 1.5 million individuals in the U.S. Recently, there has been an increased understanding of the importance of sleep and sleep disruption in IBD as a potentially modifiable risk factor. We, therefore, hypothesize that intervening with morning bright light therapy (BLT) in IBD patients with CM will decrease intestinal permeability and pro-inflammatory cytokines, positively impact intestinal microbiota, and improve quality of life (QoL).

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (2)

• Changes in intestinal permeability (% excretion of urinary sucralose)

  Participants will ingest a sugar cocktail at Visits 2-5 and complete a urine collection. Measurement of urinary sugars is done using gas chromatography is used to calculate intestinal permeability.

  15 weeks

• Changes in microbiota will be assessed using shotgun metagene sequencing and total microbial community DNA

  At all study visits, stool samples will be collected and analyzed using shotgun metagene sequencing and total microbial community DNA will be isolated and processed for microbiome analysis.

  15 weeks

Secondary Outcomes (2)

• Change in systemic markers of barrier disruption and inflammation

  15 weeks

• Change in systemic markers of inflammation

  15 weeks

Study Arms (2)

Bright Light Therapy via ReTimer glasses, Then Placebo

EXPERIMENTAL

Participants will wear their device for 60 minutes every morning for 28-days (4 weeks)

Device: Bright Light Therapy; Device: Placebo Retimer Device

No Bright Light Therapy via placebo glasses, Then Bright Light Therapy

EXPERIMENTAL

Participants will wear their placebo device for 60 minutes every morning for 28-days (4 weeks)

Device: Bright Light Therapy; Device: Placebo Retimer Device

Interventions

Bright Light Therapy DEVICE

Device: Bright Light Therapy Retimer

Bright Light Therapy via ReTimer glasses, Then Placebo; No Bright Light Therapy via placebo glasses, Then Bright Light Therapy

Placebo Retimer Device DEVICE

Device: Placebo Retimer Device with no bright light therapy

Bright Light Therapy via ReTimer glasses, Then Placebo; No Bright Light Therapy via placebo glasses, Then Bright Light Therapy

Eligibility Criteria

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

You may qualify if:

• Biopsy proven diagnosis of Crohn's or Ulcerative Colitis
• years or older
• Fecal Calprotectin \> 50 or CRP above upper limit of normal or a PROMISE Fatigue ≥ 50
• Has been on a stable dose of either a biologic, immunomodulator, or 5-ASA for at least 12 weeks

You may not qualify if:

• Active IBD (Harvey Bradshaw Index \> 5 or Modified Harvey Bradshaw Index \>5)
• Major depression (score ≥ 21 or any endorsement of suicidal intent on the Beck Depression)
• Sleep apnea (score high risk in 2 or more categories of the Berlin Questionnaire) (43)
• Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale(44))
• Regular use of medications that affect intestinal permeability, and/or endogenous melatonin including metoclopramide, NSAIDs, beta blockers, psychotropic medications, hypnotics and exogenous melatonin products during 4 weeks prior to the study
• People who have worked night shifts or crossed more than 2 time zones in the previous month
• Any major organ disease - renal impairment (creatinine\>1.2 mg/dL), diabetes (Hgb-A1c \> 6.5%); liver disease (LFTs \> 1.5x normal), or significant cardiac failure (NY classification stage III/IV)
• Diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screening
• Inability to sign an informed consent

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60068, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Ali Keshavarzian, M.D.

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Garth R Swanson, M.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daynia Sanchez-Bass

CONTACT

(312) 563-4981; daynia_sanchez-bass@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Participants will be randomly assigned to receive Bright light therapy or placebo (wearing a similar device but will not receive the therapy) for 4 weeks, then they will do a washout period. After the washout period, the same participants will crossover to the opposite group for the remaining 4 weeks of the study, i.e. placebo or bright light therapy.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 13, 2022
• Study Start: September 22, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

US (2)