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A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Ulcerative Colitis
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Ulcerative Colitis
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An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
Background: Crohn s disease (CD) is an inflammatory bowel disease. It causes inflammation of the gut. Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition. CD has no cure, but symptoms can sometimes be controlled with medicine. Researchers want to see if it is safe to treat CD with the medicine vorinostat. It is thought that vorinostat may reduce the inflammation process of CD. This may then help to relieve symptoms of CD. Participants who respond to Vorinostat will be invited to an extension phase of treatment with Vorinostat and possibly a maintenance treatment using Ustekinumab. ...
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Antimicrobial Therapy for Ulcerative Colitis (UC)
The Aim of this randoized controlled pilot study is to find a better treatment strategy for active UC based on the recent knowledge regarding the microbiota in UC and the beneficial or detrimental effects of antibiotics in restoring gut health and reducing inflammation. This study is designed to determine whether therapy with two antibiotics during a flare - amoxicillin and doxycillin, will be better than the current published antibiotic treatment combination using these antibiotics with metronidazole ( as the latter which may degrade beneficial species without adding benefit towards reducing pathobionts)
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Anti-tumor Necrosis Factor in Patients With Ulcerative Colitis in Clinical Remission: to Continue or Not?
The primary objective is to assess if discontinuation of anti- tumor necrosis factor alpha (TNF) treatment in ulcerative colitis patients in sustained clinical remission, with the option to restart treatment in the case of relapse, is non-inferior to continued anti-TNF treatment. Secondary objectives are to assess the efficacy and safety of restarting anti-TNF treatment after a relapse
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A Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease Patients
Treatment will start with dose escalation in addition to Standard of Care (steroid therapy with or without additional therapies) . At the conclusion of the dose escalation segment of the study, if the 300 mg Cannabidiol dose level/placebo is deemed safe for two weeks with Standard of care dose of steroids, patients will continue receiving this 300 mg dose/placebo for an additional period of 3 months. Weekly tapering off of steroids will then commence and will be carried out . Three months after starting treatment with Cannabidiol an interim analysis to evaluate Cannabidiol's safety and efficacy will be carried out and treatment...
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A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease
A pilot study to assess the safety and tolerability of an orally administered natural product derived from hops, called xanthohumol, in humans with Crohn's Disease, in order to identify a biological signature of xanthohumol exposure, and to characterize the role of xanthohumol metabolism by intestinal microorganisms in that signature within adults with Crohn's Disease.
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A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis. Condition or disease: Ulcerative Colitis Intervention/treatment: Drug: Etrasimod Drug: Placebo Phase: Phase 3
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A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease
The proposed study is a randomized, double-blind, placebo-controlled, multi-center Phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active Crohn's Disease. The study aims to evaluate the optimal dose of SHR0302 and time needed in inducing clinical remission in active CD. This is an 12+12 weeks study, in which participants who complete the first 12 weeks treatment phase, will have the option to enter a blinded active arms 12-week extension phase. Early withdrawn subjects during the first treatment phase cannot enter the extension phase. The total duration of the study participation,...
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A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
This is a Phase 3, randomized, double-blind, placebo-controlled study to demonstrate the effect of oral ozanimod as maintenance therapy in subjects with moderately to severely active Crohn's Disease.
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A Prospective Longitudinal Study of Fecal Microbiome and Calprotectin to Predict Response to Biological Therapy in Patients With CD
Crohn's disease (CD) is a chronic relapsing-remitting systemic inflammatory disease, affecting any part of the gastrointestinal tract. Biological therapy with anti-tumor necrosis factor (TNF) alpha is the established treatment of choice for the management of moderate to severe Crohn's disease. However, its efficacy in an individual patient is the unpredictable and long-term outcome is still suboptimal. Identifying biomarkers which can predict treatment response is thus of utmost importance and can allow personalized management. In inflammatory bowel disease (IBD), altered fecal microbiota signatures have been consistently reported....
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