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

Launched by RUSH UNIVERSITY MEDICAL CENTER · Oct 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of bright light therapy (BLT) on patients with Crohn's Disease and Ulcerative Colitis, which are types of inflammatory bowel disease (IBD). The researchers believe that using bright light in the morning may help improve gut health by reducing inflammation, strengthening the intestinal barrier, and enhancing the balance of gut bacteria. They also hope that this therapy will lead to a better quality of life for people living with these conditions.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of Crohn's Disease or Ulcerative Colitis. They should also have specific markers of inflammation or fatigue. However, those with active disease, major depression, sleep apnea, or certain other health issues will not be eligible. Participants can expect to receive bright light therapy and will be monitored to see how it affects their symptoms and overall well-being. The trial is currently recruiting participants, and anyone interested should check if they meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• 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