Inflammatory Bowel DiseaseNCT05579392
A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
A study testing Bright Light Therapy in people with Inflammatory Bowel Disease, run by Rush University Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Bright Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Sep 2022to 20 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven diagnosis of Crohn's or Ulcerative Colitis
- 18 years or older
- Fecal Calprotectin > 50 or CRP above upper limit of normal or a PROMISE Fatigue ≥ 50
- Has been on a stable dose of either a biologic, immunomodulator, or 5-ASA for at least 12 weeks
Who cannot join
- Active IBD (Harvey Bradshaw Index > 5 or Modified Harvey Bradshaw Index >5)
- Major depression (score ≥ 21 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Katy Donovan, 843-792-7974, donova@musc.edu
Garth Swanson, M.D., M.S
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60068
Daynia Sanchez-Bass, 312-563-4981, daynia_sanchez-bass@rush.edu
About this study
Official title: Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
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).
Read the 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.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Bright Light Therapy, Placebo Retimer Device
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Light TherapyDevice
Device: Bright Light Therapy Retimer
Placebo Retimer DeviceDevice
Device: Placebo Retimer Device with no bright light therapy
| Study group | Role | What they receive |
|---|---|---|
| Bright Light Therapy via ReTimer glasses, Then Placebo | Experimental | Participants will wear their device for 60 minutes every morning for 28-days (4 weeks) Receives: Device: Bright Light Therapy; Device: Placebo Retimer Device |
| No Bright Light Therapy via placebo glasses, Then Bright Light Therapy | Experimental | Participants will wear their placebo device for 60 minutes every morning for 28-days (4 weeks) Receives: Device: Bright Light Therapy; Device: Placebo Retimer Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intestinal permeability (% excretion of urinary sucralose)
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.
Measured: 15 weeks
Changes in microbiota will be assessed using shotgun metagene sequencing and total microbial community DNA
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.
Measured: 15 weeks
Secondary outcomes (2)
Change in systemic markers of barrier disruption and inflammation
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.
Measured: 15 weeks
Change in systemic markers of inflammation
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.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start22 Sep 2022
- Primary completion1 Feb 2027 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Keshavarzian, Rush University Medical Center
- Investigators
- Ali Keshavarzian, M.D., Principal investigator, Rush University Medical CenterGarth R Swanson, M.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579392
- Sponsor's protocol ID
- 22041302
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2022
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
- ClinicalTrials.gov ID
- NCT05579392
- Acronym / sponsor ID
- 22041302
- Conditions
- Inflammatory Bowel Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bright Light Therapy via ReTimer glasses, Then Placebo | Experimental | Device: Bright Light Therapy, Device: Placebo Retimer DeviceParticipants will wear their device for 60 minutes every morning for 28-days (4 weeks) |
| No Bright Light Therapy via placebo glasses, Then Bright Light Therapy | Experimental | Device: Bright Light Therapy, Device: Placebo Retimer DeviceParticipants will wear their placebo device for 60 minutes every morning for 28-days (4 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy proven diagnosis of Crohn's or Ulcerative Colitis
- 18 years or older
- Fecal Calprotectin > 50 or CRP above upper limit of normal or a PROMISE Fatigue ≥ 50
- Has been on a stable dose of either a biologic, immunomodulator, or 5-ASA for at least 12 weeks
Key exclusion criteria (9 listed)
- Active IBD (Harvey Bradshaw Index > 5 or Modified Harvey Bradshaw Index >5)
- Major depression (score ≥ 21 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Light TherapyDevice: Bright Light Therapy Retimer | Device | Bright Light Therapy via ReTimer glasses, Then Placebo, No Bright Light Therapy via placebo glasses, Then Bright Light Therapy |
| Placebo Retimer DeviceDevice: Placebo Retimer Device with no bright light therapy | Device | Bright Light Therapy via ReTimer glasses, Then Placebo, No Bright Light Therapy via placebo glasses, Then Bright Light Therapy |
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.
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.
2 secondary outcomes
Change in systemic markers of barrier disruption and inflammation
Time frame: 15 weeks
Change in systemic markers of inflammation
Time frame: 15 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Keshavarzian, M.D. principal investigator
Rush University Medical Center
Garth R Swanson, M.D. principal investigator
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Light Therapy in people with Inflammatory Bowel Disease, run by Rush University Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daynia Sanchez-Bass ((312) 563-4981, daynia_sanchez-bass@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in intestinal permeability (% excretion of urinary sucralose) (time frame: 15 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.