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

Description

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

Inflammatory Bowel Disease

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Study Overview

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Study Details

Study overview

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).

Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis

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

Condition
Inflammatory Bowel Disease
Intervention / Treatment

-

Contacts and Locations

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60068

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rush University Medical Center,

Ali Keshavarzian, M.D., PRINCIPAL_INVESTIGATOR, Rush University Medical Center

Garth R Swanson, M.D., PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

2025-05-31