Actively Recruiting
Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
Led by Rush University Medical Center · Updated on 2025-12-12
30
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Crohn's Disease and Ulcerative Colitis, together known as inflammatory bowel disease (IBD), are chronic conditions affecting the gastrointestinal tract and impacting over 1.5 million people in the U.S. This research aims to study how morning bright light therapy might help patients with IBD and chronic fatigue by reducing intestinal permeability and inflammation, improving gut bacteria balance, and enhancing quality of life. Understanding sleep disruption as a modifiable risk factor is a key focus of this trial. Participants will use a lightweight, wearable Re-Timer device that emits blue-green light for 60 minutes each morning over two 4-week periods. This is a randomized crossover trial where participants will switch between active bright light therapy and a placebo device without bright light. Before starting treatment, patients are screened for subclinical inflammation and assessed for fatigue, sleep habits, and quality of life. They will wear a wrist device to monitor fatigue objectively before intervention. Throughout the study, blood, urine, and stool samples will be collected to examine inflammation, intestinal permeability, and microbiota changes. Questionnaires and actigraphy will track symptoms and sleep patterns. The primary outcomes measured after 15 weeks include changes in intestinal permeability and gut microbiota. Secondary outcomes focus on systemic inflammation markers. The total study duration and follow-up include 15 weeks for outcome assessments.
CONDITIONS
Brief Title
A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy proven diagnosis of Crohn's Disease or Ulcerative Colitis
- 18 years or older
- Fecal Calprotectin greater than 50 or CRP above the upper limit of normal or a fatigue score of 50 or higher
- On a stable dose of biologic, immunomodulator, or 5-ASA medication for at least 12 weeks
You will not qualify if you...
- Active inflammatory bowel disease with Harvey Bradshaw Index score greater than 5
- Major depression with a score of 21 or higher or any suicidal intent
- Sleep apnea with high risk in two or more categories of the Berlin Questionnaire
- Restless leg syndrome with a score of 15 or higher
- Regular use of medications affecting intestinal permeability or melatonin in the 4 weeks before the study
- Night shift work or crossing more than 2 time zones in the previous month
- Major organ disease including renal impairment, diabetes, liver disease, or significant cardiac failure
- Diagnosis or symptoms of narrow angle glaucoma or retinal disorders
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 21 days
Participants wear a wrist actigraphy device for 21 days to objectively assess circadian misalignment before starting therapy.
Continuous wear with 1 follow-up visit
Duration - 4 weeks
Participants are randomly assigned to wear either the Bright Light Therapy Re-Timer device or the placebo device daily for 60 minutes each morning for 4 weeks.
Daily use with 2 visits (pre- and post-treatment sample collection)
Duration - 4 weeks
Participants cross over to the alternate device and wear it daily for 60 minutes each morning for another 4 weeks.
Daily use with 2 visits (pre- and post-treatment sample collection)
Trial Site Locations
Total: 2 locations
1
Rush University Medical Center
Chicago, Illinois, United States, 60068
Actively Recruiting
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
D
Daynia Sanchez-Bass
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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