Bright Light Therapy for IBS

Overseen By Keaveny (Katy) Donovan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: NSAIDs, Beta blockers, Antibiotics, others

Disqualifiers: Pregnancy, Night shift work, Major organ disease, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if bright light therapy (BLT) with a wearable device can reduce symptoms of Irritable Bowel Syndrome (IBS) and improve gut health. Participants will wear glasses that emit blue-green light each morning, simulating natural sunlight. To compare results, some participants will use glasses that do not emit bright light. This trial may suit those with noticeable IBS symptoms who tend to stay up late or have difficulty waking up early (a late chronotype). As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new insights into IBS management.

Will I have to stop taking my current medications?

If you regularly use medications that affect intestinal permeability or melatonin, like certain antibiotics, NSAIDs, or sleep aids, you would need to stop taking them 4 weeks before joining the study.

What prior data suggests that this bright light therapy device is safe for IBS patients?

Research has shown that bright light therapy (BLT), using devices like the Re-Timer, is generally easy to use. In studies, most participants reported few or no side effects from BLT. The Re-Timer glasses emit blue-green light, similar to natural sunlight, and include a UV filter to block harmful UV rays. BLT has been used safely for other conditions, suggesting it is safe for people to try. While some studies have examined its benefits, reports of serious side effects remain rare. Overall, BLT is considered a safe option for those interested in trying it for conditions like IBS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Bright Light Therapy for IBS is unique because it uses a non-invasive approach to manage symptoms by mimicking natural light exposure through a wearable device. Unlike traditional treatments for IBS, which often rely on dietary changes, medications like antispasmodics, or psychological therapies, this method delivers blue-green light at 500nm to potentially regulate bodily rhythms and improve symptoms. Researchers are excited about this approach because it offers a safe alternative that avoids the side effects common with medications and has the potential to show results in just two weeks.

What evidence suggests that bright light therapy is effective for IBS?

This trial will compare Bright Light Therapy with a placebo device to evaluate its effects on IBS symptoms. Studies have shown that bright light therapy can reset the body's internal clock, potentially improving sleep and mood. Better sleep and mood are linked to fewer symptoms in people with Irritable Bowel Syndrome (IBS). Some research suggests that light therapy might also help with "leaky gut," a condition that may contribute to IBS. While evidence for IBS is still developing, these findings suggest that bright light therapy could help manage IBS symptoms. Initial results are promising, but more research is needed to confirm its effectiveness for IBS specifically.

Who Is on the Research Team?

Caitlin Green

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals with Irritable Bowel Syndrome (IBS), who may also have Klinefelter or Triple X Syndrome. It's not clear what the specific inclusion and exclusion criteria are, but typically participants would need to meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

Late chronotype based on the Munich Chronotype Questionnaire (Corrected Midpoint of Sleep > 4:00h)

I have been diagnosed with Irritable Bowel Syndrome.

I have IBS with symptoms that are at least mild in severity.

Exclusion Criteria

Night shift workers or individuals who have crossed more than 2 time zones in the previous 4 weeks

High risk of sleep apnea in 2 or more categories of the Berlin Questionnaire

Pregnant or planning to become pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive morning bright light therapy (BLT) using Re-Timer glasses or placebo for 2 weeks, followed by a 2-week washout, then crossover to the other condition for another 2 weeks

6 weeks

Assessments at two timepoints: after 2 weeks of BLT and after 2 weeks of placebo

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bright Light Therapy

Trial Overview The study is testing if morning bright light therapy using Re-Timer glasses can improve IBS symptoms and reduce leaky gut. Participants will wear these safe, lightweight glasses that emit blue-green light similar to natural sunlight.

How Is the Trial Designed?

Group I: Re-Timer Device (Bright Light Therapy) Experimental Treatment 1 Intervention

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).

Group II: Placebo device (non Bright Light Therapy) Placebo Group 1 Intervention

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).

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A systematic review of 74 articles on low-level light therapy (LLLT) revealed that 73% of studies did not provide adequate information on how light was measured, which raises concerns about the reliability and repeatability of their findings.

Many studies misreported or omitted critical light parameters such as power, pulse frequency, and irradiance, indicating a need for better adherence to 'best practice' guidelines in light measurement to ensure effective patient treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dark art of light measurement: accurate radiometry for low-level light therapy. Hadis, MA., Zainal, SA., Holder, MJ., et al.[2022]

Broad-spectrum light (BSL) phototherapy is more effective than blue light emitting diodes (LED) phototherapy for treating jaundice in late preterm and term infants, as shown by a study involving 40 infants.

Infants receiving BSL phototherapy required significantly less treatment time (15.8 hours) compared to those receiving blue LED therapy (20.6 hours), indicating a quicker resolution of hyperbilirubinemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Broad-spectrum light versus blue light for phototherapy in neonatal hyperbilirubinemia: a randomized controlled trial. Pratesi, S., Di Fabio, S., Bresci, C., et al.[2015]

Low-level light therapy (LLLT) has been shown to be a safe and effective treatment for skin rejuvenation, acne vulgaris, and body contouring, supported by a reasonable amount of clinical trial evidence.

Despite its commercial success, the quality of evidence for LLLT is limited by methodological flaws and small sample sizes, highlighting the need for more rigorous, independent clinical trials to validate its therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation: The Clinical Applications of Low-Level Light Therapy. Glass, GE.[2022]

This study is a double-blinded, randomized controlled trial involving 32 patients with diffuse axonal injury from severe traumatic brain injury, testing the effects of transcranial LED therapy on cognitive function and cerebral circulation.

The therapy involves 18 sessions of LED stimulation over 6 weeks, and aims to improve cognitive outcomes and promote beneficial changes in blood flow to the brain, addressing a gap in clinical trials for TBI cognitive rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial LED therapy on the cognitive rehabilitation for diffuse axonal injury due to severe acute traumatic brain injury: study protocol for a randomized controlled trial. Santos, JGRPD., Zaninotto, ALC., Zângaro, RA., et al.[2023]

In a study involving 66 infants with neonatal hyperbilirubinemia, LED phototherapy showed a comparable rate of decline in total serum bilirubin levels to that of special blue fluorescent tube phototherapy after 15 hours of treatment.

The decline in bilirubin levels was 0.35 mg/dl/h for the LED group versus 0.27 mg/dl/h for the BB group, indicating that LED phototherapy is an effective alternative for treating jaundice in newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of light-emitting diode phototherapy. Maisels, MJ., Kring, EA., DeRidder, J.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06676488

A Randomized Crossover Trial of Bright Light Therapy in ... 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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1011134425001046

Therapeutic potential of wavelength-dependent ... The current study demonstrated that wavelength-dependent PBM exhibited anti-inflammatory effects in an LPS-induced in vitro intestinal model, with 635 nm ...

3. researchgate.net researchgate.net/publication/393186644_Photobiomodulation_and_its_potential_in_treating_irritable_bowel_syndrome

Photobiomodulation and its potential in treating irritable ... However, published data that describe the efficacy and safety of microbial targeted therapy in PI-IBS patients are scarce. Future research ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11110384/

Morning light treatment for inflammatory bowel disease Morning light treatment may be an acceptable, feasible, and effective adjunctive treatment for individuals with active IBD suffering from impaired health- ...

5. jkslms.or.kr jkslms.or.kr/journal/view.html?uid=385&vmd=Full&

Photobiomodulation and its potential in treating irritable bowel ... Their research indicates that red and NIR light can beneficially reshape the gut microbiome by promoting the growth of beneficial bacteria like Akkermansia and ...