Actively Recruiting
A Randomized Crossover Trial of 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
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 or Ulcerative Colitis
- 18 years or older
- Fecal Calprotectin greater than 50 or CRP above upper limit of normal or a PROMISE Fatigue score of 50 or higher
- On a stable dose of biologic, immunomodulator, or 5-ASA for at least 12 weeks
You will not qualify if you...
- Active IBD (Harvey Bradshaw Index greater than 5 or Modified Harvey Bradshaw Index greater than 5)
- Major depression (score 21 or higher or any suicidal intent on Beck Depression scale)
- High risk for sleep apnea in two or more categories of the Berlin Questionnaire
- Restless leg syndrome with a score of 15 or higher on the IRLS Rating Scale
- Regular use of medications affecting intestinal permeability or melatonin within 4 weeks prior to study (e.g., metoclopramide, NSAIDs, beta blockers, psychotropic medications, hypnotics, exogenous melatonin)
- Worked night shifts or crossed more than 2 time zones in the previous month
- Major organ diseases including renal impairment (creatinine over 1.2 mg/dL), diabetes (Hgb-A1c over 6.5%), liver disease (LFTs over 1.5x normal), or significant cardiac failure (NY classification stage III/IV)
- 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
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here