Bright Light Therapy for Crohn's Disease
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Rush University Medical Center
No Placebo Group
Approved in 1 jurisdiction
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.
12345What 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.
678910Is 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.
37111213Eligibility 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.Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: No Bright Light Therapy via placebo glasses, Then Bright Light TherapyExperimental Treatment2 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 PlaceboExperimental Treatment2 Interventions
Participants will wear their device for 60 minutes every morning for 28-days (4 weeks)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
Rush University Medical CenterChicago, IL
Loading ...
Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
References
Perioperative adjuvant therapy with infliximab in complicated anal Crohn's disease. [2021]Infliximab may represent an adjuvant to surgical therapy in patients with severe anal Crohn's disease as it has been shown to affect rapid remissions in a proportion of cases.
Early remission status predicts long-term outcomes in patients with Crohn's disease treated with certolizumab pegol. [2018]In Crohn's disease (CD), rapid response to anti-tumor necrosis factor therapy improves short- and medium-term outcomes, but the relationship between early remission (ER) and long-term remission is unclear.
Medical management of Crohn's disease: a guide for radiologists. [2009]The choice of therapies for Crohn's disease has expanded greatly over the past 30 years. Increasingly it is important that we attempt to identify subgroups of patients who will benefit most from each type of therapy. This article reviews the therapeutic options currently available, organized by the goal the practitioner hopes to achieve. Imaging is one critical way of aiding the classification of Crohn's disease by attempting to accurately determine the location, extent and, most importantly, the nature of the disease.
Long-term outcome of maintenance infliximab therapy in children with Crohn's disease. [2022]Infliximab therapy has short-term benefits in children with moderate-to-severe Crohn's disease (CD). We assessed the long-term outcome of infliximab maintenance therapy in children with CD.
Depth of remission in Crohn's disease patients seen in a referral centre : associated factors and impact on disease outcome. [2016]Our goals were to assess the prevalence of biological and tissue remission in routine practice in Crohn's disease, and to evaluate the correlation between biological or tissue remission and clinical or demographic characteristics as well as their impact on disease outcome.
Vedolizumab in the treatment of Crohn's disease. [2016]Vedolizumab, a recent addition to the therapeutic armamentarium in Crohn's disease, is promising in efficacy, durability of remission and safety. It is the first gut selective biologic treatment, acting by targeting α4β7-integrin, a receptor expressed on activated lymphocytes and binding to MAdCAM1, a cell adhesion molecule selectively expressed in the circulatory system of the digestive tract, preventing trafficking of lymphocytes to the gut. The pivotal GEMINI studies have demonstrated the efficacy and safety of vedolizumab in achieving clinical response and clinical remission in patients with moderately to severely active CD who are naïve or have previously failed therapy with TNF-antagonists, immunomodulators or dependent on steroids. Vedolizumab had a favorable safety profile and specifically showed no evidence of PML, reactivation of latent TB or hepatitis B. Overall, the number of malignancies in the clinical trials was small; however, long-term exposure was limited. Vedolizumab can be given as a first-line therapy or following treatment failure, and was tolerated as part of combination therapy. More medications with similar and novel therapeutic mechanisms are anticipated in the coming years.
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]Biotherapies targeting TNFα were proven to be effective in the most severe cases of Crohn's Disease, a chronic granulomatous inflammatory bowel disease that can involve any portion of the digestive tract. The tolerance of anti-TNFα therapy is usually good, although several infectious complications have been reported with these drugs.
Infliximab for the treatment of Crohn's disease: efficacy, safety and pharmacoeconomics. [2015]Crohn's disease is a chronic inflammatory disorder of the gastrointestinal tract. From the perspective of the patient, symptoms of the disease significantly impair quality of life and interfere with activities of daily living. Conventional medical treatment of Crohn's disease includes the use of nonspecific anti-inflammatory drugs, immunosuppressives and antibiotics. These therapies are characterized by a delayed onset of action, incomplete response rates and a substantial risk of adverse effects. Although surgery is frequently used to treat complications, postoperative recurrence is an important problem. Infliximab, a chimeric monoclonal antibody directed toward tumour necrosis factor alpha, is highly effective for the treatment of active Crohn's disease. In randomized, placebo-controlled clinical trials, 82% of patients who received 5 mg/kg of infliximab had a clinically significant response, compared with 17% of those given placebo (P
De-escalation of biological treatment in inflammatory bowel disease: A comprehensive review. [2023]Biological therapy is an effective treatment for inflammatory bowel disease (IBD). However, due to cost and safety concerns, after achieving remission, dose de-escalation strategies have been suggested.
[Anti-TNF (infliximab) treatment in Crohn disease: safety profile]. [2019]Anti-tumor necrosis factor (anti-TNF) therapy is an important therapeutic addition in the treatment of active Crohn's disease. Although controlled trials have confirmed the efficacy of anti-TNF (infliximab) treatment, serious toxicities related to the therapies have emerged. The purpose of this article was to review the safety profile of infliximab, and in particular analyse the infectious complications, the autoimmune disorders and the theoretical risk of cancer and lymphoma.
Management of Crohn's disease--a practical approach. [2015]Crohn's disease is a chronic inflammatory disorder of the gastrointestinal tract that affects up to 480,000 persons in the United States. Symptoms include abdominal pain, diarrhea, fever, malaise, and arthralgias, and cause considerable morbidity. Speculation about genetic, environmental, dietary, infectious, and immunologic etiologies has led to treatment modalities directed at each theoretic cause, but therapy guidelines are determined by the severity of disease. Use of salicylates and/or antibiotics can be effective in mild to moderate disease, while steroids are the accepted therapy for more severe active disease. Azathioprine and other immunosuppresant drugs can be used as adjunctive therapy for active Crohn's disease and may help to maintain remission. Infliximab, an antibody to human tumor necrosis factor alpha, has proved successful in the treatment of severe refractory disease and generally causes only mild side effects. Therapy for Crohn's disease must involve treating comorbid conditions to improve the quality of life of patients.
Update in medical treatment of Crohn's disease. [2019]Crohn's disease is an inflammatory bowel disorder that has no known cause. The goal of medical treatment is to control active disease, induce and maintain clinical remission, and treat complications. Anti-inflammatory medications and immunomodulatory therapies are the primary treatment modalities for Crohn's disease. The categories of standard treatment include the 5-aminosalicylic acid compounds, corticosteroids, antibiotics, and immunomodulators. New biologic therapy has been developed to better target the immune mediators that are active in Crohn's disease. Infliximab is the first of the biologic agents approved for the treatment of fistulizing and active Crohn's disease. Despite medical advances in treatment, there is still no cure for Crohn's disease.
Infliximab induces potent anti-inflammatory and local immunomodulatory activity but no systemic immune suppression in patients with Crohn's disease. [2019]Anti-TNFalpha therapy with infliximab is effective for Crohn's disease. Infliximab neutralizes the biological activities of TNFalpha, a cytokine involved in host-defence against certain infections.