Clinical trial NCT06676488: A Randomized Crossover Trial of Bright Light Therapy in Irritable Bowel Syndrome
Official title: A Randomized Crossover Trial of Bright Light Therapy in Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome (IBS)
Circadian Misalignment
Keywords: Stomach
Irritable Bowel Syndrome
Circadian Misalignment
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-11-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to assess whether morning bright light therapy (BLT) using a wearable device called a Re-Timer could potentially improve Irritable Bowel Syndrome (IBS) symptoms and decrease intestinal permeability (leaky gut). Morning bright light therapy will be administrated through a safe-wearable glasses device called a Re-Timer. The Re-Timer glasses are lightweight and deliver blue-green light at 500nm, mimicking exposure to natural light.

Detailed description: The hypothesis of this study is that morning bright light therapy (BLT) using Re-Timer™ glasses in irritable bowel syndrome (IBS) patients with circadian misalignment (CM), will improve IBS symptom severity, improve circadian misalignment, decrease intestinal permeability and improve stool microbial diversity. Our overall objective is to assess the effects of morning bright light therapy on IBS symptom severity, circadian misalignment, intestinal permeability and intestinal microbiota. We propose to conduct a 6-week, single center, randomized, crossover pilot trial involving 30 subjects with active IBS symptoms (IBS-SSS \>75), and circadian misalignment (CM) based on late chronotype (Munich Chronotype Questionnaire, Corrected Midpoint of Sleep \> 4:00h). Subjects will be randomized to BLT or placebo with a 2-week washout between each condition. All subjects will have assessments at two timepoints: after 2 weeks of BLT, and after 2 weeks of placebo.

Eligibility criteria: Inclusion Criteria

* 18-65 years old
* Irritable Bowel Syndrome based on Rome IV diagnostic criteria
* Mild to severe IBS symptom severity based on IBS-SSS greater than or equal to 75 17.
* Late chronotype based on the Munich Chronotype Questionnaire (Corrected Midpoint of Sleep \> 4:00h) 18 Exclusion Criteria
* Subject that are pregnant or plan to become pregnant.
* Night shift workers or people who have crossed more than 2 time zones in the previous 4 weeks.
* Regular use of medications that affect intestinal permeability, and/or endogenous melatonin including metoclopramide, NSAIDs, beta blockers, antibiotics, psychotropic medications, hypnotics and exogenous melatonin products during 4 weeks prior to the study.
* Any major organ disease - known renal impairment, diabetes, liver disease, or significant cardiac failure (NY classification stage III/IV), inflammatory bowel disease or celiac disease per chart review and/or medical history.
* Diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screening.
* Moderate to severe depression (score ≥ 21 or any endorsement of suicidal intent on the Beck Depression Inventory) 19
* Sleep apnea (score high risk in 2 or more categories of the Berlin Questionnaire) 20
* Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale) 21
* Inability or unwillingness of subject to sign an informed consent

Primary outcomes:
measure: Aim 1a
timeFrame: 2 weeks of morning Bright Light Therapy (BLT)
measure: Aim 1b
timeFrame: 2 weeks of morning Bright Light Therapy (BLT)
Secondary outcomes:
measure: Aim 2
timeFrame: 2 weeks of morning Bright Light Therapy (BLT)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Caitlin Green
role: PRINCIPAL_INVESTIGATOR
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