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A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis

Sponsored by Rush University Medical Center

About this study

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).

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). IBD affects over 1.5 million individuals in the US, so identifying risk factors for disease flares is essential to avoid complications, such as hospitalizations and surgery, and to improve quality of life (QoL). Recently, there has been an increased understanding of the importance of sleep and sleep disruption in IBD as a potentially modifiable risk factor. Bright light therapy (BLT) in IBD patients with CM may decrease intestinal permeability and pro-inflammatory cytokines, positively impact intestinal microbiota, and improve quality of life (QoL).In order to administer BLT efficiently and safely,…

Where this study is enrolling (2)

Who can participate

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

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Trial data sourced from ClinicalTrials.gov.