Irritable Bowel Syndrome (IBS)NCT06676488
A Randomized Crossover Trial of Bright Light Therapy in Irritable Bowel Syndrome
A study testing Re-Timer glasses in people with Irritable Bowel Syndrome (IBS) and Circadian Misalignment, run by Medical University of South Carolina at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome (IBS), Circadian Misalignment
- What is being tested?
- Re-Timer glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the 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.
- Being tested
- Re-Timer glasses, Placebo Device
- Keywords
- Stomach, Irritable Bowel Syndrome, Circadian Misalignment
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-Timer glassesDevice
Morning bright light therapy (BLT) will be administered through a safe wearable glasses device called a Re-Timer, purchased from the manufacturer Re-Timer.
Placebo DeviceDevice
Placebo glasses not providing Bright Light Therapy
| Study group | Role | What they receive |
|---|---|---|
| Re-Timer Device (Bright Light Therapy) | Experimental | Morning bright light therapy will be administrated through a safe wearable device called a Re-timer. The Re-Timer glasses are lightweight and deliver blue-green light at 500nm, mimicking exposure to natural light. The device emits light at a higher wavelength than the UV range and has a UV filter for added safety. Subjects will be asked to wear the glasses for one hour each morning per day for 7 days a week. They will wear the device for a total of 14 days to receive the full therapeutic effect. Additionally, subjects will be asked to complete the light therapy the first hour of being awake and remain indoors while using the device. Participants will be informed that they can wear the device freely throughout their home or work environment but should avoid activities that could potentially be harmful (i.e., driving, contact sports, operating heavy machinery). Receives: Device: Re-Timer glasses |
| Placebo device (non Bright Light Therapy) | Placebo comparator | Subjects will be asked to wear glasses that do not provide Bright Light Therapy for one hour each morning per day for 7 days a week as recommended by the manufacturer. They will wear the device for a total of 14 days to receive the full therapeutic effect. Additionally, subjects will be asked to complete the light therapy the first hour of being awake and remain indoors while using the device. Participants will be informed that they can wear the device freely throughout their home or work environment but should avoid activities that could potentially be harmful (i.e., driving, contact sports, operating heavy machinery). Receives: Device: Placebo Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1a
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).
Measured: 2 weeks of morning Bright Light Therapy (BLT)
Aim 1b
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).
Measured: 2 weeks of morning Bright Light Therapy (BLT)
Secondary outcomes (1)
Aim 2
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.
Measured: 2 weeks of morning Bright Light Therapy (BLT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start11 Jun 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome (IBS)Studies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caitlin Green, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676488
- Sponsor's protocol ID
- Pro00138575
- Other IDs
- P30DK123704
- Status last verified
- Apr 2026
- First submitted
- 4 Nov 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walters AS, LeBrocq C, Dhar A, Hening W, Rosen R, Allen RP, Trenkwalder C; International Restless Legs Syndrome Study Group. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med. 2003 Mar;4(2):121-32. doi: 10.1016/s1389-9457(02)00258-7.
PubMed 14592342Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr;11(2):395-402. doi: 10.1046/j.1365-2036.1997.142318000.x.
PubMed 914678119. Beck AT, Steer RA, Brown G. Beck Depression Inventory-II (BDI-II). APA PsycTests. 1996.
Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999 Oct 5;131(7):485-91. doi: 10.7326/0003-4819-131-7-199910050-00002.
PubMed 10507956Roenneberg T, Wirz-Justice A, Merrow M. Life between clocks: daily temporal patterns of human chronotypes. J Biol Rhythms. 2003 Feb;18(1):80-90. doi: 10.1177/0748730402239679.
PubMed 12568247Terman M, Terman JS. Bright light therapy: side effects and benefits across the symptom spectrum. J Clin Psychiatry. 1999 Nov;60(11):799-808; quiz 809.
PubMed 10584776Pail G, Huf W, Pjrek E, Winkler D, Willeit M, Praschak-Rieder N, Kasper S. Bright-light therapy in the treatment of mood disorders. Neuropsychobiology. 2011;64(3):152-62. doi: 10.1159/000328950. Epub 2011 Jul 29.
PubMed 21811085Micic G, Lovato N, Gradisar M, Ferguson SA, Burgess HJ, Lack LC. The etiology of delayed sleep phase disorder. Sleep Med Rev. 2016 Jun;27:29-38. doi: 10.1016/j.smrv.2015.06.004. Epub 2015 Jul 3.
PubMed 26434674Butler T, Maidstone JR, Rutter KM, McLaughlin TJ, Ray WD, Gibbs EJ. The Associations of Chronotype and Shift Work With Rheumatoid Arthritis. J Biol Rhythms. 2023 Oct;38(5):510-518. doi: 10.1177/07487304231179595. Epub 2023 Jun 29.
PubMed 37382359Hashemipour S, Yazdi Z, Mahabad N. Association of Evening Chronotype with Poor Control of Type 2 Diabetes: Roles of Sleep Duration and Insomnia Level. Int J Endocrinol Metab. 2020 Aug 30;18(3):e99701. doi: 10.5812/ijem.99701. eCollection 2020 Jul.
PubMed 33281907Piche T, Barbara G, Aubert P, Bruley des Varannes S, Dainese R, Nano JL, Cremon C, Stanghellini V, De Giorgio R, Galmiche JP, Neunlist M. Impaired intestinal barrier integrity in the colon of patients with irritable bowel syndrome: involvement of soluble mediators. Gut. 2009 Feb;58(2):196-201. doi: 10.1136/gut.2007.140806. Epub 2008 Sep 29.
PubMed 18824556Hanning N, Edwinson AL, Ceuleers H, Peters SA, De Man JG, Hassett LC, De Winter BY, Grover M. Intestinal barrier dysfunction in irritable bowel syndrome: a systematic review. Ther Adv Gastroenterol. 2021 Feb 24;14:1756284821993586. doi: 10.1177/1756284821993586. eCollection 2021.
PubMed 33717210Nojkov B, Rubenstein JH, Chey WD, Hoogerwerf WA. The impact of rotating shift work on the prevalence of irritable bowel syndrome in nurses. Am J Gastroenterol. 2010 Apr;105(4):842-7. doi: 10.1038/ajg.2010.48. Epub 2010 Feb 16.
PubMed 20160712Voigt RM, Forsyth CB, Green SJ, Mutlu E, Engen P, Vitaterna MH, Turek FW, Keshavarzian A. Circadian disorganization alters intestinal microbiota. PLoS One. 2014 May 21;9(5):e97500. doi: 10.1371/journal.pone.0097500. eCollection 2014.
PubMed 24848969Codoner-Franch P, Gombert M. Circadian rhythms in the pathogenesis of gastrointestinal diseases. World J Gastroenterol. 2018 Oct 14;24(38):4297-4303. doi: 10.3748/wjg.v24.i38.4297.
PubMed 30344415
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Trial of Bright Light Therapy in Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06676488
- Acronym / sponsor ID
- Pro00138575
- Keywords
- Stomach, Irritable Bowel Syndrome, Circadian Misalignment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 6 Nov 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Re-Timer Device (Bright Light Therapy) | Experimental | Device: Re-Timer glassesMorning bright light therapy will be administrated through a safe wearable device called a Re-timer. The Re-Timer glasses are lightweight and deliver blue-green light at 500nm, mimicking exposure to natural light. The device emits light at a higher wavelength than the UV range and has a UV filter for added safety. Subjects will be asked to wear the glasses for one hour each morning per day for 7 days a week. They will wear the device for a total of 14 days to receive the full therapeutic effect. Additionally, subjects will be asked to complete the light therapy the first hour of being awake and remain indoors while using the device. Participants will be informed that they can wear the device freely throughout their home or work environment but should avoid activities that could potentially be harmful (i.e., driving, contact sports, operating heavy machinery). |
| Placebo device (non Bright Light Therapy) | Placebo comparator | Device: Placebo DeviceSubjects will be asked to wear glasses that do not provide Bright Light Therapy for one hour each morning per day for 7 days a week as recommended by the manufacturer. They will wear the device for a total of 14 days to receive the full therapeutic effect. Additionally, subjects will be asked to complete the light therapy the first hour of being awake and remain indoors while using the device. Participants will be informed that they can wear the device freely throughout their home or work environment but should avoid activities that could potentially be harmful (i.e., driving, contact sports, operating heavy machinery). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Re-Timer glassesMorning bright light therapy (BLT) will be administered through a safe wearable glasses device called a Re-Timer, purchased from the manufacturer Re-Timer. | Device | Re-Timer Device (Bright Light Therapy) |
| Placebo DevicePlacebo glasses not providing Bright Light Therapy | Device | Placebo device (non Bright Light Therapy) |
Primary outcome
Aim 1a
Time frame: 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
Time frame: 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).
1 secondary outcome
Aim 2
Time frame: 2 weeks of morning Bright Light Therapy (BLT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 14592342Walters AS, LeBrocq C, Dhar A, Hening W, Rosen R, Allen RP, Trenkwalder C; International Restless Legs Syndrome Study Group. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med. 2003 Mar;4(2):121-32. doi: 10.1016/s1389-9457(02)00258-7.
- Background: PubMed 9146781Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr;11(2):395-402. doi: 10.1046/j.1365-2036.1997.142318000.x.
- Background19. Beck AT, Steer RA, Brown G. Beck Depression Inventory-II (BDI-II). APA PsycTests. 1996.
- Background: PubMed 10507956Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999 Oct 5;131(7):485-91. doi: 10.7326/0003-4819-131-7-199910050-00002.
- Background: PubMed 12568247Roenneberg T, Wirz-Justice A, Merrow M. Life between clocks: daily temporal patterns of human chronotypes. J Biol Rhythms. 2003 Feb;18(1):80-90. doi: 10.1177/0748730402239679.
- Background: PubMed 10584776Terman M, Terman JS. Bright light therapy: side effects and benefits across the symptom spectrum. J Clin Psychiatry. 1999 Nov;60(11):799-808; quiz 809.
- Background: PubMed 21811085Pail G, Huf W, Pjrek E, Winkler D, Willeit M, Praschak-Rieder N, Kasper S. Bright-light therapy in the treatment of mood disorders. Neuropsychobiology. 2011;64(3):152-62. doi: 10.1159/000328950. Epub 2011 Jul 29.
- Background: PubMed 26434674Micic G, Lovato N, Gradisar M, Ferguson SA, Burgess HJ, Lack LC. The etiology of delayed sleep phase disorder. Sleep Med Rev. 2016 Jun;27:29-38. doi: 10.1016/j.smrv.2015.06.004. Epub 2015 Jul 3.
- Background: PubMed 37382359Butler T, Maidstone JR, Rutter KM, McLaughlin TJ, Ray WD, Gibbs EJ. The Associations of Chronotype and Shift Work With Rheumatoid Arthritis. J Biol Rhythms. 2023 Oct;38(5):510-518. doi: 10.1177/07487304231179595. Epub 2023 Jun 29.
- Background: PubMed 33281907Hashemipour S, Yazdi Z, Mahabad N. Association of Evening Chronotype with Poor Control of Type 2 Diabetes: Roles of Sleep Duration and Insomnia Level. Int J Endocrinol Metab. 2020 Aug 30;18(3):e99701. doi: 10.5812/ijem.99701. eCollection 2020 Jul.
- Background: PubMed 18824556Piche T, Barbara G, Aubert P, Bruley des Varannes S, Dainese R, Nano JL, Cremon C, Stanghellini V, De Giorgio R, Galmiche JP, Neunlist M. Impaired intestinal barrier integrity in the colon of patients with irritable bowel syndrome: involvement of soluble mediators. Gut. 2009 Feb;58(2):196-201. doi: 10.1136/gut.2007.140806. Epub 2008 Sep 29.
- Background: PubMed 33717210Hanning N, Edwinson AL, Ceuleers H, Peters SA, De Man JG, Hassett LC, De Winter BY, Grover M. Intestinal barrier dysfunction in irritable bowel syndrome: a systematic review. Ther Adv Gastroenterol. 2021 Feb 24;14:1756284821993586. doi: 10.1177/1756284821993586. eCollection 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Caitlin Green principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-Timer glasses in people with Irritable Bowel Syndrome (IBS) and Circadian Misalignment, run by Medical University of South Carolina at 1 site 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 13 inclusion and 0 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: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1a (time frame: 2 weeks of morning Bright Light Therapy (BLT)). 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?
On the ClinicalTrials.gov record for NCT06676488, which also lists 21 linked publications.
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 7 Apr 2026.