View clinical trials related to Crohn Disease.
Filter by:Spondyloarthritis and inflammatory bowel diseases are common diseases, frequently met together in overlap syndromes. Their physiopathology remains puzzling. A strong role of gut microbiota has been recently put forward to explain the development of inflammatory bowel diseases, and is suspected to play an important role in rheumatoid diseases. Anti-Tumor Necrosis Factor (anti-TNF) alpha are effective and safe drugs in the treatment of both digestive and rheumatoid inflammatory diseases. The way they work is unclear, and the clinical response to this treatment is variable. A better understanding of the pathophysiology of inflammatory bowel diseases and of the action of anti-TNF alpha is essential to an optimized care. Our hypothesis is that the efficacy of anti-TNF alpha in spondyloarthritis and in inflammatory bowel diseases is at least partly due to its restoring action of homeostasis at the interface between gastrointestinal mucosa and intestinal microbiota, either by primary action on the digestive epithelium, allowing it to regain its control and tolerance functions toward mucosal microbiota, either by direct action on the intestinal microbiota, via an inter-reigns regulation. The main objective of our study is to assess quantitative and qualitative changes in fecal microbiota before (D0) and 3 months after initiation of anti-TNF alpha.
The purpose of the study is to evaluate the ability of subjects who are already prescribed Certolizumab Pergol therapy and have been self injecting with prefilled syringes for at least the previous three months, to safely and effectively self-inject Certolizumab Pegol (CZP) using the e-Device and to evaluate the post-use structural integrity of used devices and cassettes via visual examination.
Ustekinumab is a fully human Immune Globulin Gk (IgGk) monoclonal antibody against the common p40 subunit of interleukin-12 and interleukin-23, which are implicated in the pathogenesis of inflammatory bowel disease. Its efficiency to induce and maintain clinical response in patients with anti TNF resistant Crohn's disease has been proved in several clinical trials, and the profile of safety of this treatment was good, but the investigators have few data about biological characteristics of patients treated by Ustekinumab, particularly about ustekinumab through levels and rate of patients developing anti ustekinumab antibodies during the induction and maintenance stages, and no predictive factors of clinical response have been identified yet. The aim of this study will be to assess the evolution of biological markers of inflammation and ustekinumab trough levels and antibodies, in responders and non responders patients treated by ustekinumab, in order to identify predictive factors of clinical response. The investigators will perform a prospective observational study, including the patients followed in the University hospital center of Lyon and treated by ustekinumab for a moderate to severe Crohn's disease (with a HBI scoreā„4 ). All the patients included will have been previously treated by at least one anti TNF and/or Vedolizumab, with specified criteria for a primary non response, a secondary loss of response or unacceptable side effects. Then, clinical and biological data will be collected for each patient at the inclusion, and then at weeks 4, 8, 16, 24: HBI score, sides effects, extra intestinal manifestations, steroids withdraw, CRP, calprotectin, ustekinumab trough levels and ustekinumab antibodies. The investigators will compare responding and non responding patients at week 16 (end of the induction period) according to these data. The hypothesis the investigators state is that an early and significant decrease of the inflammation markers in blood and stools associated with a high ustekinumab through level in blood is associated with a clinical response at week 16 in the patients treated by ustekinumab
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).
IBD adds additional stressors as a chronic disease that has unpredictable and sometimes embarrassing symptoms to the normal challenges that teenagers face. Stress and how stressful events are perceived, may contribute to worsening of disease. Complementary and alternative medicine (CAM), are used often by pediatric IBD patients and maybe beneficial in decreasing stress and improving quality of life. Yoga could be a well suited paring with standard medical therapy to decrease and provide a better sense of control and improve quality of life.
The purpose of this study is to assess the PK of vedolizumab following a single intravenous infusion in healthy adult Chinese participants.
A series of N-of-1 trials will be used to determine the effectiveness of a specific carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and inflammatory burden at both the individual and population level. This is a four-year study. The study staff will recruit up to 60 patients across up to 21 sites in patients aged 7-18 with mild to moderate disease activity.
The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)
The PREdiCCt Study: This is a major study that is now being launched. This is the first study of its kind and is specifically directed toward understanding how environmental factors and the gut microorganisms influence IBD flare and recovery. For the PREdiCCt study, the investigators hope to recruit 3100 people in remission from Crohn's disease or ulcerative colitis (illness under control) from 28 inflammatory bowel disease clinics across the UK. The investigators hope to conduct the study in the following stages;- 1. Patients with Crohn's disease, ulcerative colitis or inflammatory bowel disease unclassified (IBDU) in clinical remission (under control) will be approached in gastroenterology clinics across the country and invited to take part in the PREdiCCt study. Alternatively they will express their interest in the study after seeing PREdiCCt promotional leaflets/posters/videos/social media. 2. Participants will attend a clinic visit for routine tests and also to complete several questionnaires with a research nurse. 3. At home over the next week participants will complete detailed questionnaires assessing their environment and diet. Participants will also collect a stool and saliva sample and send this to our laboratories (the investigators have developed easy ways of doing this reliably by post). The stool sample is to analyse the microorganisms in the participant's gut and the saliva is used to analyse their DNA. In addition to this the participants are asked to complete a 4-day weighed food diary. The food diary is sent to the University of Aberdeen for analysis. 4. Investigators will then follow patients' progress over 24 months. They will be asked to complete a short questionnaire every month with a longer questionnaire after 12 months and culminating in a final questionnaire 24 months after their initial clinic visit. 5. If a participant experiences a flare, investigators will collect an additional stool sample; but most importantly investigators will look to see how the environmental and microorganism factors recorded at the beginning differ for those that flare up versus those that don't. What investigators hope to achieve;- 1. Finding out the environmental and dietary factors for patients to avoid because they trigger flare. 2. Finding out behaviours for patients to adopt because they bring about remission. 3. Finding out what the microorganisms that predict flare look like. 4. Gaining information which helps future studies aimed at finding better diets for IBD sufferers. 5. Developing ways of gathering information online from IBD patients about their well-being that doctors can routinely use. The investigators have assembled expert doctors, epidemiologists, microbiologists, nutrition scientists, and bioinformaticians. These experts will use the systems the investigators have put in place to make sure PREdiCCt succeeds. It will yield a lot of new information to help sufferers right away; but the information will also help to kick start many important future studies that will bring us ever closer to a cure for Crohn's disease and ulcerative colitis.