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

Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis

This study is testing if bright light therapy can help improve gut health and reduce inflammation in people with Crohn's disease and ulcerative colitis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rush University Medical Center (Academic / other)
• Locations: 2 sites (Chicago, Illinois and 1 other locations)
• Trial ID: NCT05579392 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a biopsy-proven diagnosis of Crohn's disease or ulcerative colitis who meet specific inflammatory criteria.

Not a fit: Patients with active inflammatory bowel disease, major depression, sleep apnea, or those on certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve the quality of life and health outcomes for patients with Crohn's disease.

How similar studies have performed: While the use of bright light therapy is a novel approach in this context, other studies have shown promising results in related areas of sleep and inflammation management.

Eligibility criteria

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 this trial is running

Chicago, Illinois and 1 other locations

• 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

Conditions Inflammatory Bowel Disease