Bright Light Therapy for Crohn's Disease

Recruiting at 1 trial location

Overseen By Daynia Sanchez-Bass

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Must be taking: Biologics, Immunomodulators, 5-ASA

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

Disqualifiers: Active IBD, Major depression, Sleep apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether bright light therapy can improve health and quality of life for people with Crohn's Disease or Ulcerative Colitis, both chronic digestive conditions. Participants will wear special glasses for an hour each morning for four weeks, with some starting with a placebo before switching to the actual therapy. The researchers aim to determine if this therapy can reduce gut inflammation and improve sleep, potentially easing symptoms. Individuals with a confirmed diagnosis of Crohn's or Ulcerative Colitis who have been on stable medication for at least three months without severe symptoms might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment options for these conditions.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you must stop taking your current medications. However, you must have been on a stable dose of a biologic, immunomodulator, or 5-ASA for at least 12 weeks to participate. You cannot regularly use medications that affect intestinal permeability or melatonin, like metoclopramide, NSAIDs, beta blockers, psychotropic medications, hypnotics, and melatonin products, during the 4 weeks before the study.

What prior data suggests that Bright Light Therapy is safe for Crohn's Disease?

Studies have shown that morning light treatment might safely and effectively help people with inflammatory bowel disease (IBD). Research indicates that bright light therapy can be practical when used alongside other treatments.

This trial is not linked to a specific testing phase, meaning it is still under exploration. So far, no major safety issues have emerged. Other studies have not reported significant side effects from the treatments being tested, which is encouraging for participants considering this therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Bright Light Therapy for Crohn's Disease because it offers a non-pharmacological approach that could complement or even enhance current treatments like anti-inflammatory drugs and biologics. Unlike standard therapies that primarily target the immune system, Bright Light Therapy uses a new mechanism by harnessing light exposure via specialized glasses to potentially regulate circadian rhythms and reduce inflammation. This method is not only innovative but also user-friendly, as it involves simply wearing the glasses for an hour each morning, making it a potentially convenient option for patients.

What evidence suggests that Bright Light Therapy is effective for Crohn's Disease?

Research suggests that bright light therapy (BLT) might help people with inflammatory bowel disease (IBD), such as Crohn's disease. In this trial, participants will receive either BLT or a placebo device. Studies have found that morning light therapy can be practical and beneficial for those with active IBD, possibly leading to better health. Bright light therapy has been linked to reducing intestinal leakiness and lowering levels of substances that cause inflammation. This therapy might also improve gut bacteria balance and enhance overall quality of life. Although more research is needed, these early findings indicate that BLT could be a promising way to manage Crohn's disease symptoms. ^{1 2 4 5 6}

Who Is on the Research Team?

Ali Keshavarzian, MD

Principal Investigator

Rush University Medical Center

Garth R Swanson, M.D.

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults with Crohn's or Ulcerative Colitis who have stable inflammatory markers and have been on consistent medication for their condition. It excludes those with active IBD, major organ disease, recent night shift work or extensive travel, certain eye diseases, severe depression, sleep apnea, restless leg syndrome, or use of drugs affecting intestinal permeability.

Inclusion Criteria

I have a biopsy-confirmed diagnosis of Crohn's disease or Ulcerative Colitis.

I have signs of inflammation according to my tests.

I have been on a consistent dose of my medication for at least 12 weeks.

Exclusion Criteria

I do not have severe kidney, liver, diabetes, or heart failure issues.

People who have worked night shifts or crossed more than 2 time zones in the previous month

My inflammatory bowel disease is under control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

1 visit (in-person)

Pre-Treatment Assessment

Participants complete questionnaires and wear a wrist actigraphy for 21 days to assess circadian misalignment (CM) prior to initiating therapy

3 weeks

1 visit (in-person)

Treatment

Participants are randomly assigned to wear either the Re-Timer device for bright light therapy (BLT) or a placebo device for 4 weeks

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in systemic markers of barrier disruption, inflammation, intestinal permeability, and microbiota

5 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bright Light Therapy
• Placebo Retimer Device

Trial Overview The study tests if bright light therapy in the morning can help people with Crohn's Disease by reducing gut inflammation and improving quality of life compared to a placebo device. Participants will switch between the real treatment and placebo at some point during the trial.

How Is the Trial Designed?

Group I: No Bright Light Therapy via placebo glasses, Then Bright Light Therapy Experimental Treatment 2 Interventions

Participants will wear their placebo device for 60 minutes every morning for 28-days (4 weeks)

Group II: Bright Light Therapy via ReTimer glasses, Then Placebo Experimental Treatment 2 Interventions

Participants will wear their device for 60 minutes every morning for 28-days (4 weeks)

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

A 54-year-old Crohn's disease patient developed severe pulmonary cryptococcosis after being treated with adalimumab and azathioprine, highlighting a potential risk of opportunistic infections associated with anti-TNFα therapy.

The case suggests that exposure to chicken manure, a source of Cryptococcus spp., poses a contamination risk, indicating that patients on immunosuppressive therapy should avoid such environmental exposures, especially in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary cryptococcosis in a patient with Crohn's disease treated with prednisone, azathioprine and adalimumab: exposure to chicken manure as a source of contamination. Fraison, JB., Guilpain, P., Schiffmann, A., et al.[2016]

Vedolizumab is an effective and safe treatment for Crohn's disease, specifically targeting α4β7-integrin to prevent lymphocyte trafficking to the gut, as shown in pivotal GEMINI studies involving patients with moderately to severely active disease.

The drug has a favorable safety profile, with no reported cases of progressive multifocal leukoencephalopathy (PML) or reactivation of latent infections like tuberculosis or hepatitis B, making it a suitable option for both first-line therapy and after previous treatment failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vedolizumab in the treatment of Crohn's disease. Tarabar, D., Hirsch, A., Rubin, DT.[2016]

Anti-TNF therapy, specifically infliximab, is effective in treating active Crohn's disease, as confirmed by controlled trials.

However, the use of infliximab is associated with serious safety concerns, including increased risks of infections, autoimmune disorders, and potential links to cancer and lymphoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Anti-TNF (infliximab) treatment in Crohn disease: safety profile]. Carroccio, A., Di Prima, L., Pirrone, G., et al.[2019]

Infliximab therapy was safely administered to 19 patients undergoing anal reconstructive surgery for severe anal Crohn's disease, with only one minor adverse event reported.

Eighty-four percent of patients had favorable outcomes, with eight achieving complete clinical remission and a high success rate (82%) for surgical procedures, suggesting infliximab may enhance surgical results in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative adjuvant therapy with infliximab in complicated anal Crohn's disease. Kraemer, M., Kirschmeier, A., Marth, T.[2021]

In a study of 729 pediatric patients with Crohn's disease, infliximab maintenance therapy demonstrated long-term effectiveness, with 26% of patients achieving clinically inactive disease within the first year and maintaining this status over three years.

The therapy significantly reduced the need for corticosteroids, with less than 10% of patients on maintenance infliximab requiring corticosteroids by the end of the first year, indicating a successful management strategy for children with moderate-to-severe Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome of maintenance infliximab therapy in children with Crohn's disease. Hyams, JS., Lerer, T., Griffiths, A., et al.[2022]

In a study of 263 Crohn's disease patients, two-thirds of those in clinical remission also achieved biological (69%) or tissue remission (66%), indicating that these remissions are common in routine practice.

Patients with biological or tissue remission experienced significantly longer time-to-relapse compared to those without, suggesting that achieving these remissions leads to better long-term outcomes in managing Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depth of remission in Crohn's disease patients seen in a referral centre : associated factors and impact on disease outcome. Poncin, M., Reenaers, C., Van Kemseke, C., et al.[2016]

Crohn's disease is a chronic inflammatory bowel disorder with no known cause, and while treatments aim to control symptoms and maintain remission, there is currently no cure.

Infliximab, a biologic therapy, is the first approved treatment specifically targeting the immune response in active and fistulizing Crohn's disease, representing a significant advancement in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update in medical treatment of Crohn's disease. Regueiro, MD.[2019]

The range of therapies for Crohn's disease has significantly increased over the past 30 years, highlighting the need to identify specific patient subgroups that will benefit most from each treatment option.

Imaging plays a crucial role in classifying Crohn's disease by accurately assessing its location, extent, and characteristics, which can guide more effective treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical management of Crohn's disease: a guide for radiologists. Helper, DJ.[2009]

Infliximab, an anti-TNFalpha therapy, effectively normalizes immune cell counts in patients with Crohn's disease, showing significant changes in leukocyte populations without broadly suppressing the immune system.

The treatment primarily exerts local anti-inflammatory effects in the gut, as evidenced by decreased Th1 cytokine production in the lamina propria, while maintaining systemic immune function, indicating a targeted mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infliximab induces potent anti-inflammatory and local immunomodulatory activity but no systemic immune suppression in patients with Crohn's disease. Cornillie, F., Shealy, D., D'Haens, G., et al.[2019]

Infliximab is highly effective for treating active Crohn's disease, with 82% of patients showing a significant response compared to only 17% with placebo, making it a strong option for those not responding to conventional treatments.

It is particularly effective for fistulizing Crohn's disease, but while infusion reactions are common, the long-term safety regarding risks of cancer, infections, or autoimmune diseases needs further study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infliximab for the treatment of Crohn's disease: efficacy, safety and pharmacoeconomics. Feagan, BG., Enns, R., Fedorak, RN., et al.[2015]

In a review of 12 studies involving 1,474 patients, it was found that 34% of patients who had their biologic therapy dose intensified were able to safely de-escalate to standard dosing, but the relapse rate for those de-escalating from standard dosing was higher at 38%.

Therapeutic drug monitoring of anti-TNF treatments can help guide de-escalation decisions, but de-escalation does not consistently improve safety, and the cost-effectiveness of this strategy remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

De-escalation of biological treatment in inflammatory bowel disease: A comprehensive review. Gisbert, JP., Chaparro, M.[2023]

In a study of patients with Crohn's disease receiving certolizumab pegol, those who achieved early remission (ER) within the first 6 weeks had a significantly longer time to loss of remission, averaging 2.77 years compared to 1.14 years for those without ER (p < 0.0001).

This suggests that achieving early remission is a strong predictor of long-term clinical remission in Crohn's disease, highlighting the importance of rapid response to anti-tumor necrosis factor therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early remission status predicts long-term outcomes in patients with Crohn's disease treated with certolizumab pegol. Melmed, GY., McGovern, D., Schreiber, S., et al.[2018]

Crohn's disease affects up to 480,000 people in the U.S. and can cause significant symptoms like abdominal pain and diarrhea, requiring treatment based on disease severity.

Infliximab, an antibody targeting tumor necrosis factor alpha, is effective for severe cases of Crohn's disease and typically has mild side effects, making it a valuable option for patients with refractory disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Crohn's disease--a practical approach. Knutson, D., Greenberg, G., Cronau, H.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06146816

The Assessment of Infrared Treatment for Crohn's Disease The goal of this clinical trial is to test the safety and efficacy of far Infra-red (fIR) therapy in Crohn's disease patients.

2. 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- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10835098/

The effectiveness of photobiomodulation therapy in ... Photobiomodulation therapy (PBMT), which is the use of red (630-700 nm), and near-infrared light (700 and 1200 nm), can stimulate healing, relieve pain, and ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1011134420304681

Red light-emitting diode treatment improves tissue ... LED treatment decreased the amount of crypt dysplasia/edema, inflammatory infiltrates and ulcers, attenuated apoptosis and increased proliferation of crypt ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05579392?locStr=United%20States&country=United%20States&distance=50&cond=IBD-Inflammatory%20Bowel%20Disease&term=Microbiome&aggFilters=status:not%20rec&rank=7

A Randomized Crossover Trial of Bright Light Therapy in ... A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis. ClinicalTrials.gov ID NCT05579392. Sponsor Rush ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10216148/

A Holistic Perspective on How Photobiomodulation May ... Photobiomodulation, through an integrated effect on the neuroimmune and microbiome–gut–brain axis, has the potential to be effective in managing the fatigue, ...