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

Sponsor

Rush University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05579392

Collaborator

(none)

Enrollment

Location

Arms

8.2

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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). 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, QoL, 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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease	Device: Bright Light Therapy Device: Placebo Retimer Device	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Sep 22, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bright Light Therapy via ReTimer glasses, Then Placebo Participants will wear their device for 60 minutes every morning for 28-days (4 weeks)	Device: Bright Light Therapy Device: Bright Light Therapy Retimer Device: Placebo Retimer Device Device: Placebo Retimer Device with no bright light therapy
Experimental: No Bright Light Therapy via placebo glasses, Then Bright Light Therapy Participants will wear their placebo device for 60 minutes every morning for 28-days (4 weeks)	Device: Bright Light Therapy Device: Bright Light Therapy Retimer Device: Placebo Retimer Device Device: Placebo Retimer Device with no bright light therapy

Arm

Intervention/Treatment

Experimental: Bright Light Therapy via ReTimer glasses, Then Placebo

Participants will wear their device for 60 minutes every morning for 28-days (4 weeks)

Device: Bright Light Therapy

Device: Bright Light Therapy Retimer

Device: Placebo Retimer Device

Device: Placebo Retimer Device with no bright light therapy

Experimental: No Bright Light Therapy via placebo glasses, Then Bright Light Therapy

Participants will wear their placebo device for 60 minutes every morning for 28-days (4 weeks)

Device: Bright Light Therapy

Device: Bright Light Therapy Retimer

Device: Placebo Retimer Device

Device: Placebo Retimer Device with no bright light therapy

Outcome Measures

Primary Outcome Measures

Changes in intestinal permeability (% excretion of urinary sucralose) [15 weeks]
Participants will ingest a sugar cocktail at Visits 2-5 and complete a urine collection. Measurement of urinary sugars is done using gas chromatography is used to calculate intestinal permeability.
Changes in microbiota will be assessed using shotgun metagene sequencing and total microbial community DNA [15 weeks]
At all study visits, stool samples will be collected and analyzed using shotgun metagene sequencing and total microbial community DNA will be isolated and processed for microbiome analysis.

Secondary Outcome Measures

Change in systemic markers of barrier disruption and inflammation [15 weeks]
Inflammatory cytokines (IL-6, TNF-α, and IL-8) are the markers of disruption. IL-6, IL-8, and TNF-α will be measured in the plasma.
Change in systemic markers of inflammation [15 weeks]
markers of endotoxemia (LPS, LBP, and sCD14) will be used to assess inflammation. Lipopolysaccharide binding protein(LBP) and sCD14 will be measured in serum by high sensitivity ELISA. Lipopolysaccharide (LPS) will be measured in serum using a LAL assay which is a quantitative, kinetic assay for the detection of Gram-negative bacterial endotoxin.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Biopsy proven diagnosis of Crohn's or Ulcerative Colitis
18 years or older
Fecal Calprotectin > 50 or CRP > 5 or a FACIT Score ≥ 4
Has been on a stable dose of either a biologic, immunomodulator, or 5-ASA for at least 12 weeks

Exclusion Criteria:

Active IBD (Harvey Bradshaw Index < 5 or Modified Harvey Bradshaw Index <5)
Major depression (score ≥ 15 or any endorsement of suicidal intent on the Beck Depression)
Sleep apnea (score high risk in 2 or more categories of the Berlin Questionnaire) (43)
Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale(44))
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
People who have worked night shifts or crossed more than 2 time zones in the previous month
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)
Diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screening
Inability to sign an informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60068

Sponsors and Collaborators

Rush University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Garth Swanson, MD, Principle Investigator, Rush University Medical Center

ClinicalTrials.gov Identifier:

NCT05579392

Other Study ID Numbers:

22041302

First Posted:

Oct 13, 2022

Last Update Posted:

Oct 13, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Crohn Disease

Inflammatory Bowel Diseases

Study Results

No Results Posted as of Oct 13, 2022