RecruitingNot ApplicableNCT05579392

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

Sponsor

Rush University Medical Center

Enrollment

30 participants

Start Date

Sep 22, 2022

Study Type

INTERVENTIONAL

Conditions

Inflammatory Bowel Disease

Summary

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria9

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)
Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale(44))
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
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)
Diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screening
Inability to sign an informed consent