Circadian Misalignment, Irritable Bowel Syndrome (IBS)
Conditions
Keywords
Stomach, Irritable Bowel Syndrome, Circadian Misalignment
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.
Interventions
DEVICERe-Timer glasses
Morning bright light therapy (BLT) will be administered through a safe wearable glasses device called a Re-Timer, purchased from the manufacturer Re-Timer.
DEVICEPlacebo Device
Placebo glasses not providing Bright Light Therapy
Sponsors
Medical University of South Carolina
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aim 1a | 2 weeks of morning Bright Light Therapy (BLT) | In Aim 1a, we predict 2 weeks of morning BLT in IBS subjects with CM will improve IBS-symptom severity based on the IBS Severity Scoring Scale as compared to the control (wear the Re-Timer™ glasses without light therapy). |
| Aim 1b | 2 weeks of morning Bright Light Therapy (BLT) | In Aim 1b, we predict 2 weeks of morning BLT will improve circadian misalignment as accessed by wrist actigraphy (interdaily stability, intradaily variability, and relative amplitude). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aim 2 | 2 weeks of morning Bright Light Therapy (BLT) | Aim 2, we will evaluate the impact of BLT on intestinal barrier homeostasis in IBS as measured by 2a) intestinal permeability, urinary sucralose percent excretion after oral challenge and 2b) stool microbiota diversity using 16S ribosomal RNA sequencing. We predict that BLT will decrease intestinal permeability and improve stool microbiota diversity and structure. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCaitlin Green
Medical University of South Carolina
Outcome results
None listed