Using bright light therapy to improve intestinal health in Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of bright light therapy (BLT) on patients with Crohn's disease and ulcerative colitis, focusing on its potential to enhance intestinal barrier function and reduce inflammation. Participants will be screened for subclinical inflammation and will use a wearable device that emits blue-green light to receive the therapy. The study aims to assess changes in intestinal permeability, inflammatory markers, and overall quality of life through questionnaires and wrist actigraphy. The goal is to determine if BLT can serve as a beneficial intervention for managing symptoms of inflammatory bowel disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Biopsy proven diagnosis of Crohn's or Ulcerative Colitis
2. 18 years or older
3. Fecal Calprotectin \> 50 or CRP above upper limit of normal or a PROMISE Fatigue ≥ 50
4. Has been on a stable dose of either a biologic, immunomodulator, or 5-ASA for at least 12 weeks

Exclusion Criteria:

1. Active IBD (Harvey Bradshaw Index \> 5 or Modified Harvey Bradshaw Index \>5)
2. Major depression (score ≥ 21 or any endorsement of suicidal intent on the Beck Depression)
3. Sleep apnea (score high risk in 2 or more categories of the Berlin Questionnaire) (43)
4. Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale(44))
5. 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
6. People who have worked night shifts or crossed more than 2 time zones in the previous month
7. 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)
8. Diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screening
9. Inability to sign an informed consent

Where it's running

• Rush University Medical Center
  Chicago, Illinois, United States Recruiting
• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Ali Keshavarzian, M.D. — Rush University Medical Center
• Study coordinator: Daynia Sanchez-Bass
• Email: daynia_sanchez-bass@rush.edu
• Phone: (312) 563-4981

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.