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

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ClinicalTrials.gov Identifier: NCT05579392
Recruitment Status : Recruiting
First Posted : October 13, 2022
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
Garth Swanson, MD, Rush University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Device: Bright Light Therapy Device: Placebo Retimer Device Not Applicable

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, 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
Actual Study Start Date : September 22, 2022
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Changes in intestinal permeability (% excretion of urinary sucralose) [ Time Frame: 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.

  2. Changes in microbiota will be assessed using shotgun metagene sequencing and total microbial community DNA [ Time Frame: 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 :
  1. Change in systemic markers of barrier disruption and inflammation [ Time Frame: 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.

  2. Change in systemic markers of inflammation [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05579392


Contacts
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Contact: Netanel Zilberstein 818-439-7871 Netanel_F_Zilberstein@rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60068
Contact: Netanel Zilberstein    818-439-7871    Netanel_F_Zilberstein@rush.edu   
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Netanel Zilberstein Rush University Medical Center
More Information
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Responsible Party: Garth Swanson, MD, Principle Investigator, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT05579392    
Other Study ID Numbers: 22041302
First Posted: October 13, 2022    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases