Inflammatory Bowel Disease
Bright Light Therapy and Intestinal Barrier Health in Crohn’s Disease or Colitis
This study examines how morning bright light therapy affects intestinal permeability, inflammation, microbiota, and quality of life in adults with Crohn’s disease or ulcerative colitis who show subjective and objective evidence of circadian misalignment.
Registry title: A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
2 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- Bright Light Therapy or Placebo Retimer Device
- Design
- Randomized · Single
- Central study contact
- Daynia Sanchez-Bass(312) 563-4981daynia_sanchez-bass@rush.edu
- Sponsor
- Rush University Medical Center
Research question
Does morning bright light therapy change intestinal permeability, inflammatory markers, intestinal microbiota, or quality of life in people with inflammatory bowel disease and circadian misalignment?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older with a biopsy-proven diagnosis of Crohn’s disease or ulcerative colitis.
- The study is looking for people with fecal calprotectin above 50, C-reactive protein above the normal limit, or a PROMIS Fatigue score of at least 50.
- The study is looking for people who have taken a stable dose of a biologic, immunomodulator, or 5-aminosalicylic acid medication for at least 12 weeks.
- Potential participants must show both subjective and wrist-actigraphy evidence of circadian misalignment before random assignment.
- Recruiting locations are listed in Chicago, Illinois, and Charleston, South Carolina.
Participation overview
What participation may involve
After inflammation screening, questionnaires, and 21 days of wrist actigraphy, participants who meet the study requirements are randomized to the order of two four-week device periods, with a washout between them. What participation may involve: - Screening includes fecal calprotectin and a blood test for subclinical inflammation. - Participants complete questionnaires about diet, fatigue, sleep, quality of life, and disease severity. - Participants wear a wrist actigraphy device for 21 days to assess circadian misalignment before therapy begins. - Participants wear either bright-light or placebo Re-Timer glasses for 60 minutes every morning during each four-week device period. - Blood, urine, and stool samples are collected to assess inflammation, endotoxemia, intestinal permeability, and intestinal microbiota. The record specifies 21 days of actigraphy followed by two four-week device periods separated by a washout, but it does not state the washout length or the total participation duration. The record says urine collection occurs at Visits 2 through 5 and stool is collected at all study visits, but it does not provide a complete visit schedule.
Study interventions
What participants may receive or do
- Bright Light Therapy: Participants wear Re-Timer glasses that emit blue-green light for 60 minutes each morning during a 28-day bright-light treatment period.
- Placebo Retimer Device: Participants wear a similar Re-Timer device for 60 minutes each morning during a 28-day period, but the device does not provide bright light therapy.
Study design
How the comparison works
This is a randomized crossover study: participants complete one four-week period with bright light therapy and one four-week period with the placebo device, separated by a washout period. Participants are randomly assigned to the order in which they receive bright light therapy and the placebo device. The study is single-masked, with participants listed as the masked group. Each participant serves as a comparison across the bright-light and placebo-device periods in the crossover design. The placebo is a similar Re-Timer device that does not provide bright light therapy; every participant is scheduled to use it during one four-week period.
Reported activities
Procedures and tests
- Fecal calprotectin testing and a blood test are used during screening for subclinical inflammation.
- Questionnaires assess dietary habits, fatigue, sleep habits, quality of life, and underlying disease severity.
- Wrist actigraphy is worn for 21 days to objectively assess circadian misalignment.
- Participants ingest a sugar cocktail at Visits 2 through 5 and collect urine for intestinal-permeability testing.
- Urinary sugars are measured using gas chromatography to calculate intestinal permeability.
- Stool samples are collected at study visits for microbiome analysis using shotgun metagenomic sequencing and microbial-community DNA.
- Plasma is tested for the inflammatory cytokines interleukin-6, interleukin-8, and tumor necrosis factor alpha.
- Serum is tested for markers of endotoxemia, including lipopolysaccharide, lipopolysaccharide-binding protein, and soluble CD14.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- A biopsy must have confirmed Crohn’s disease or ulcerative colitis.
- Participants must be age 18 or older.
- At least one of the following is required: fecal calprotectin above 50, C-reactive protein above the normal limit, or a PROMIS Fatigue score of at least 50.
- A biologic, immunomodulator, or 5-aminosalicylic acid medication must have been taken at a stable dose for at least 12 weeks.
Possible reasons someone may not be able to join
- People with active inflammatory bowel disease, defined here as a Harvey-Bradshaw Index or Modified Harvey-Bradshaw Index above 5, are excluded.
- Major depression, defined as a score of at least 21 or any endorsement of suicidal intent on the Beck Depression assessment, is exclusionary.
- A high risk of sleep apnea in at least two Berlin Questionnaire categories is exclusionary.
- Restless leg syndrome with a score of at least 15 on the International Restless Legs Syndrome Study Group Rating Scale is exclusionary.
- Regular use within the four weeks before the study of listed medications or products that affect intestinal permeability or melatonin is exclusionary.
- People who worked night shifts or crossed more than two time zones during the previous month are excluded.
- Specified major kidney, diabetic, liver, or cardiac conditions are exclusionary, using the laboratory and severity thresholds stated by the registry.
- A diagnosis of narrow-angle glaucoma or a retinal disorder, or symptoms suggesting either condition during screening, is exclusionary.
- Anyone unable to sign informed consent is excluded.
Important unknowns
What the record does not make clear
- The record mentions a follow-up visit, Visits 2 through 5, and stool collection at all visits, but it does not give the complete number, timing, or length of visits.
- The record describes 21 days of actigraphy and two four-week device periods but does not report the washout length or total time for an individual participant.
- A stable biologic, immunomodulator, or 5-aminosalicylic acid dose is required, but the record does not clearly state whether that treatment must remain unchanged throughout participation.
- The eligibility criteria exclude regular use of several listed medications and products during the four weeks before the study, but do not explain whether stopping them is permitted or how use during the study is handled.
- The record does not describe how an inflammatory bowel disease flare or other clinical worsening would be treated during participation.
- The record requires a biopsy-proven diagnosis but does not say whether any endoscopy or biopsy is performed as part of the study.
- The record does not explain which study-related or routine-care costs are covered or billed to insurance.
- The record does not state whether participants receive compensation.
- The record does not state whether transportation, parking, lodging, or other travel support is available.
- The record lists physical study sites but does not state whether any visits or activities can be completed remotely.
- The record does not describe whether participants can keep or access a bright-light device after completing the study.
Before contacting the site
Questions for the study team
- What is the complete visit schedule, and which visits require travel to the study site?
- How long is the washout period, and what is the total expected participation time?
- Must my inflammatory bowel disease medications remain unchanged throughout the study?
- What should happen if my symptoms worsen or I develop an inflammatory bowel disease flare?
- Does the study require a new endoscopy or biopsy?
- Which costs are covered, is compensation offered, and is travel or parking support available?
- Can any visits, questionnaires, monitoring, or sample collections be completed remotely?
Before changing care
Questions for your gastroenterologist
- Would keeping my current biologic, immunomodulator, or 5-aminosalicylic acid dose stable be appropriate for my disease?
- Do my current disease activity and recent test results suggest that a research-team discussion would be reasonable?
- Do any of my medications fall within the study’s four-week exclusion involving medicines that affect intestinal permeability or melatonin?
- What approved treatment alternatives should I understand while considering whether to contact this study?
- How should your office and the research team coordinate if my symptoms, laboratory results, or treatment needs change?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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).
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.
Study design and administration
- Organization
- Rush University Medical Center
- Organization class
- Other
- Organization study ID
- 22041302
- Lead sponsor
- Rush University Medical Center
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Crossover
- Primary purpose
- Basic Science
- Masking
- Single
- Who is masked
- Participant
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Bright Light Therapy via ReTimer glasses, Then Placebo
Participants will wear their device for 60 minutes every morning for 28-days (4 weeks)
Interventions: Device: Bright Light Therapy, Device: Placebo Retimer Device
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)
Interventions: Device: Bright Light Therapy, Device: Placebo Retimer Device
Interventions
Device
Bright Light Therapy
Device: Bright Light Therapy Retimer
Device
Placebo Retimer Device
Device: Placebo Retimer Device with no bright light therapy
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (4)
- Biopsy proven diagnosis of Crohn's or Ulcerative ColitisRegistry-derived · unreviewed
- 18 years or olderRegistry-derived · unreviewed
- Fecal Calprotectin \> 50 or CRP above upper limit of normal or a PROMISE Fatigue ≥ 50Registry-derived · unreviewed
- Has been on a stable dose of either a biologic, immunomodulator, or 5-ASA for at least 12 weeksRegistry-derived · unreviewed
Exclusion criteria (9)
- Active IBD (Harvey Bradshaw Index \> 5 or Modified Harvey Bradshaw Index \>5)Registry-derived · unreviewed
- Major depression (score ≥ 21 or any endorsement of suicidal intent on the Beck Depression)Registry-derived · unreviewed
- Sleep apnea (score high risk in 2 or more categories of the Berlin Questionnaire) (43)Registry-derived · unreviewed
- Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale(44))Registry-derived · unreviewed
- 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 studyRegistry-derived · unreviewed
- People who have worked night shifts or crossed more than 2 time zones in the previous monthRegistry-derived · unreviewed
- 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)Registry-derived · unreviewed
- Diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screeningRegistry-derived · unreviewed
- Inability to sign an informed consentRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
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.
Primary outcome
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
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.
Secondary outcome
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.
Recruiting locations in the United States
Rush University Medical Center
RecruitingChicago, Illinois, 60068, United States
Daynia Sanchez-Bass312-563-4981daynia_sanchez-bass@rush.edu
Medical University of South Carolina
RecruitingCharleston, South Carolina, 29425, United States
Katy Donovan843-792-7974donova@musc.edu
Garth Swanson, M.D., M.S
Central study contacts
Registry dates
- First posted
- Oct 13, 2022
- Primary completion
- Sep 1, 2026
- Overall completion
- Oct 31, 2026
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.