View clinical trials related to Crohn Disease.
Filter by:Diagnostic validity of [18F]FSPG for assessing disease activity will be assessed in subjects with inflammatory bowel disease.
Adequate bowel preparation is required for magnetic resonance enterography (MRE) which can be achieved by two methods including administering contrast solution after mid-gut tubing and taking contrast solution orally. We present the design of randomized controlled trial to compare the efficacy and compliance of bowel preparation through mid-gut tubing with taking contrast orally for MRE in patients with Crohn's disease (CD).
The purpose of this study is to characterize the treatment patterns associated with biologics agents use or non-biological therapy in participants with moderate to severe Ulcerative Colitis (UC) and Crohn's Disease (CD).
There is limited data to guide the use of dietary change in the management of IBD, and it can prove challenging to implement in the setting of altered anatomy, comorbid conditions, and patient compliance. Therefore there is an important need to study diet as a therapy for IBD. Here, the investigators propose a novel study to evaluate the feasibility and efficacy of the autoimmune protocol (AIP) diet in patients with active Crohn's disease (CD) and ulcerative colitis (UC).
Primary: Nutritional therapy in the form of a whole-food based smoothie can be used to induce remission of active Crohn's disease. Secondary: Consuming a whole foods based smoothie will result in measurable changes to the microbiome of individuals with Crohn's disease and healthy controls. The specific aims of this proposal are: 1. To develop a whole-food based smoothie, based on principles of the specific carbohydrate diet, that is comparable in macronutrients and micronutrients to formulas used for exclusive enteral nutritional (EEN) therapy in Crohn's disease. 2. To evaluate the ability of a whole-food based smoothie to induce remission of active Crohn's disease. 3. To evaluate changes to the intestinal microbiome in healthy individuals consuming a whole-food based smoothie diet.
The CDEIS (Crohn's disease endoscopic index of severity) and its derivative, SES-CD (single endoscopic score for Crohn's disease) were constructed to evaluate the endoscopic severity of Crohn's disease (CD). The current therapeutic goal in CD is endoscopic remission, which is thought to be predictive of a favourable evolution of the disease. However, up to now there is no measure of endoscopic remission, objectively constructed and validated, not even a consensus for its definition. An objective measure of endoscopic remission is necessary, notably for the evaluation of new treatments, a request of the regulatory agencies (FDA and EMA), but also in clinical practice if one wishes to adapt the treatment of patient according to the level of endoscopic remission. The aim of the study is to construct a measure of endoscopic remission based on an objective assessment (depth or grade) of remission, that must be reproducible, little or not dependent on the reader interpreting the endoscopy. The CREDO 1 program is a cross-sectional study designed to construct objectively a measure of the endoscopic remission of CD through an index measuring its depth or a score measuring its grade and to evaluate its reproducibility. This study is composed of four main parts: 1. Training and selection of readers: - Selection and definition of all lesions to be studied at consensus meetings, first between the central readers, then with the participation of local investigators. - Specific training of local investigators in the recognition of endoscopic lesions - Checking the performance of the central readers 2. Recruitment of patients by investigators - local readers: - Inclusion criteria: CD diagnosed for more than 6 months, in clinical remission for at least 3 months, with a Crohn's disease activity index < 150 at the time of endoscopy. - Each local investigator will have to record 15 videos divided according to his/her overall judgment into 3 status of remission: Complete Remission; Remission almost complete; Remission neither complete nor nearly complete. - The colon will be divided into 7 segments: ileum, ileocecal valve, right colon, transverse colon, descending colon, sigmoid colon and rectum. Each segment will be identified by landmarks. - Videos will be anonymized and then centralized at a healthcare provider (OVH - SAS). - 16 French and Belgian centers will participate in the study leading to a total of 240 films. 3. Analysis of videos by central readers: - 12 central readers will independently read 80 out of the 240 videos - Videos allocation to central readers will be performed through balanced incomplete block method to ensure that each central reader, as well as each central reader pair, has the same weight in achieving the results. - A quantitative evaluation of the depth of endoscopic remission on a visual analogue scale and a qualitative evaluation of the grade of remission on a 5-level ordinal scale will be provided by each central reader, segment by segment and globally, in addition to the description of all lesions identified by segment. 4. Analysis of the data recorded by the central readers: - An index (depth of remission) or score (grade of remission) will be constructed from linear or multiple logistic regression models, considering the reader and endoscopy as random factors, to take into account the dependence between the readings performed on different endoscopies by the same central reader or on the same endoscopy by different readers. - Variations in readings between central readers will be quantified through the Kappa coefficient for qualitative items and through the intraclass correlation coefficient for quantitative items. In an observational longitudinal multi-center cohort study (CREDO 2), it will be tested whether the index or score thus constructed is able to predict prolonged clinical remission for 2 years in patients in clinical remission at baseline. If this test is successful, we will have a primary objective and reproducible criterion for evaluating treatments in CD and a useful tool for the management of these patients in clinical practice.
It is often suggested that lymphatic vessels are ineffective in transporting cargo in Crohn's disease. Our own work on surgically resected tissue supports this concept (1), but the concept has not been directly tested. Chylomicrons are packaged lipids from the diet with an obligatory absorption route through the lymphatic vasculature to reach host plasma. This protocol takes an approach to directly quantify chylomicron secretion using a fatty meal that incorporates stable isotopic tracers for trioleate and cholesterol in the meal. We will collect baseline plasma and then plasma every 30 minutes for 6 hours to chart the kinetic and magnitude of chylomicron secretion and transport in all subjects using mass spectrometry analysis. We will characterize a wide variety of parameters on the chylomicrons as well using ELISA. Infusions i.v. of stable isotope labeled triglyceride and glycerol will allow us to consider whether there are changes in VLDL metabolism that could account for differences in chylomicron handling once the chylomicrons are secreted into plasma. Collection and analysis of breath samples will also be carried to normalize against possible incomplete lipid absorption in some subjects.
The main purpose of this study is to assess ustekinumab's ability to induce clinical response and remission ("effectiveness") at Week 16 and remission at Week 52 and Week 104 in participants with Crohn's disease (CD). Response and remission will be assessed using clinical parameters. Retention rate at week 52 and 104 will also be studied.
The purpose of this study is to evaluate the percentage of moderate to severe IBD participants with active disease at Day 1.
The purpose of this study is to determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage and antibiotics with or without an antifungal) in the management of active Crohn's Disease (CD) or indeterminate colitis (IBDU) that is refractory to conventional, immunosuppressive therapy. In addition, the study will determine the effect of PEG lavage alone on fecal calprotectin and gut microbiota in patients who are undergoing a PEG lavage for clinical care.