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

Trial Summary

What is the purpose of this trial?

Crohn's Disease (CD) and Ulcerative Colitis (UC), collectively known as inflammatory bowel disease (IBD), are two of the most significant chronic conditions of the gastrointestinal tract (GIT) and affects over 1.5 million individuals in the U.S. Recently, there has been an increased understanding of the importance of sleep and sleep disruption in IBD as a potentially modifiable risk factor. We, therefore, hypothesize that intervening with morning bright light therapy (BLT) in IBD patients with CM will decrease intestinal permeability and pro-inflammatory cytokines, positively impact intestinal microbiota, and improve quality of life (QoL).

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 data supports the idea that Bright Light Therapy for Crohn's Disease is an effective treatment?

The available research does not provide any data supporting the effectiveness of Bright Light Therapy for Crohn's Disease. Instead, the studies focus on other treatments like infliximab and certolizumab pegol, which are drugs used to manage Crohn's Disease. These studies highlight the benefits of these drugs in achieving remission and improving outcomes for patients with Crohn's Disease. There is no mention of Bright Light Therapy being used or tested for this condition in the provided research. ^{1 2 3 4 5}

What safety data exists for Bright Light Therapy in Crohn's Disease?

The provided research does not contain safety data for Bright Light Therapy or its related terms in the context of Crohn's Disease. The studies focus on other treatments like Vedolizumab and anti-TNF therapies such as Infliximab, discussing their safety profiles and potential complications. No information on the safety of Bright Light Therapy or its variants is available in the given research. ^{6 7 8 9 10}

Is Bright Light Therapy a promising treatment for Crohn's Disease?

The provided research articles do not mention Bright Light Therapy as a treatment for Crohn's Disease. They focus on other treatments like anti-inflammatory drugs and biologic therapies. Therefore, there is no information to suggest that Bright Light Therapy is a promising treatment for Crohn's Disease based on these articles. ^{3 7 11 12 13}

Research Team

Ali Keshavarzian, MD

Principal Investigator

Rush University Medical Center

Garth R Swanson, M.D.

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Perioperative adjuvant therapy with infliximab in complicated anal Crohn's disease. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Early remission status predicts long-term outcomes in patients with Crohn's disease treated with certolizumab pegol. [2018]

3. Ireland pubmed.ncbi.nlm.nih.gov

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

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

Long-term outcome of maintenance infliximab therapy in children with Crohn's disease. [2022]

5. Belgium 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. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Vedolizumab in the treatment of Crohn's disease. [2016]

7. England 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. [2016]

8. Canada pubmed.ncbi.nlm.nih.gov

Infliximab for the treatment of Crohn's disease: efficacy, safety and pharmacoeconomics. [2015]

9. England pubmed.ncbi.nlm.nih.gov

De-escalation of biological treatment in inflammatory bowel disease: A comprehensive review. [2023]

10. Italy pubmed.ncbi.nlm.nih.gov

[Anti-TNF (infliximab) treatment in Crohn disease: safety profile]. [2019]

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

Management of Crohn's disease--a practical approach. [2015]

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

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

13. England 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. [2019]