NCT05579392Recruiting
A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Sept 2022
- Start date
- 22 Sept 2022
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Rush University Medical Center
- Diseases
- Crohn's disease
- NCT number
- NCT05579392
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 22 Sept 2022 to the primary completion date, 1 Feb 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale(44))
- Diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screening
Lab values
- 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)
Other
- 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)
- Inability to sign an informed consent
Who the study is looking for
- Biopsy proven diagnosis of Crohn's or Ulcerative Colitis
- 18 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.