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

Trial Summary

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.

How is Bright Light Therapy different from other treatments for IBS?

Bright Light Therapy is unique because it uses red or near-infrared light to stimulate tissue, potentially enhancing cellular activity and reducing oxidative stress, which is different from traditional IBS treatments that often focus on medication or dietary changes. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Caitlin Green

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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

Pregnant or planning to become pregnant

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Broad-spectrum light versus blue light for phototherapy in neonatal hyperbilirubinemia: a randomized controlled trial. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of light-emitting diode phototherapy. [2013]

4. England pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

The dark art of light measurement: accurate radiometry for low-level light therapy. [2022]