Clinical trial NCT05579392: A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
Official title: Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Disease
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned to receive Bright light therapy or placebo (wearing a similar device but will not receive the therapy) for 4 weeks, then they will do a washout period. After the washout period, the same participants will crossover to the opposite group for the remaining 4 weeks of the study, i.e. placebo or bright light therapy.
Primary purpose: BASIC_SCIENCE

Brief 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).

Detailed 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). 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, a Re-Timer device, which is a lightweight, wearable set of glasses that emits blue-green light. Please note, the FDA has determined this device to be a General Wellness product and is not regulated by the FDA.

Prior to starting treatment, IBD patients will be screened for subclinical inflammation using a fecal calprotectin (FC) level and a blood test. If no subclinical inflammation is detected, potential subjects will be informed of their ineligibility. Eligible participants will complete questionnaires assessing their dietary habits, fatigue, sleep habits, quality of life, and severity of their underlying disease. Participants will also be provided a wrist actigraphy, which is a watch like device, to wear for 21 days to objectively assess CM prior to initiating therapy. Once the subjects demonstrate both subjective and objective evidence of CM, during their follow-up visit they will be randomly assigned to wear either the Re-Timer device to receive BLT or the placebo Re-Timer device (non BLT) for 4 weeks. Prior to and following receiving BLT or non BLT placebo, the following samples will be obtained: i) serum markers of inflammation and endotoxemia, ii) urine samples to test for intestinal permeability, and iii) stool samples to assess intestinal microbiota. These proposed studies will assess whether BLT has an impact on IBD patients' inflammation, intestinal permeability, and intestinal microbiota.

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

Primary outcomes:
measure: Changes in intestinal permeability (% excretion of urinary sucralose)
timeFrame: 15 weeks
measure: Changes in microbiota will be assessed using shotgun metagene sequencing and total microbial community DNA
timeFrame: 15 weeks
Secondary outcomes:
measure: Change in systemic markers of barrier disruption and inflammation
timeFrame: 15 weeks
measure: Change in systemic markers of inflammation
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Rush University Medical Center
name: Ali Keshavarzian, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Garth R Swanson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: