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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Bright Light Therapy

Device: Bright Light Therapy Retimer

DEVICE

Placebo Retimer Device

Device: Placebo Retimer Device with no bright light therapy

Locations (2)

Rush University Medical Center
Chicago, Illinois, United States
Medical University of South Carolina
Charleston, South Carolina, United States