NIH Substudy of AIN457 (Anti-IL-17 Monoclonal Antibody) for Treatment of Moderate to Severe Crohn's...
ColitisCrohn's Disease1 moreThe objective of this NIH-specific substudy is immunologic monitoring of cytokine and immune cell responses in subjects undergoing treatment with AIN457 (human monoclonal anti-human interleukin-17A) for moderate to severe Crohn's disease. Recent data suggests that interleukin-17 (IL-17) is an important mediator of inflammation in certain animal models of Crohn's disease, and treatment aimed at blocking the IL-23-IL-17 axis can ameliorate the inflammatory changes. In addition, elevated expression of IL-l7 has been found in the gut tissue of patients with active Crohn's disease. This substudy will measure changes in cytokine production, relevant RNA expression, and immune cell populations (in the periphery and lamina propria) for correlation with clinical outcomes in order to explore the mechanisms of therapeutic response.
Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated...
Rectovaginal FistulaCrohn DiseaseThe purpose of this study is to determine safety and efficacy of allogenic eASCs (expanded adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s disease.
Trial of a Treatment Algorithm for the Management of Crohn's Disease
Crohn's DiseaseAssess if the implementation of a treatment algorithm will improve the management of Crohn's disease (CD) in comparison to usual care based gastroenterology practices.
Study Investigating Tailored Treatment With Infliximab for Active Crohn's Disease
Crohn's DiseaseTo investigate whether sustained trough levels of IFX can be achieved using IFX (Infliximab) trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorithms in comparison with 'standard of care' IFX treatment and its effects on clinical and endoscopic outcomes.
Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Crohn's...
Iron Deficiency AnaemiaInflammatory Bowel Disease1 moreThe purpose of this study is to determine whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with non-active Crohn's Disease (CD).
9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's...
Crohn´s DiseaseThis study aims to evaluate the efficacy of 9 mg budesonide once daily (OD) versus 3 mg budesonide three-times daily (TID) for the induction of remission in Crohn's disease.
Treatment of Fistulous Crohn's Disease by Implant of Autologous Mesenchymal Stem Cells Derived From...
Crohn DiseasePrimary outcome measure: Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse events occurred during the study. Secondary outcome measures: Evaluating the Adipose-derived mesenchymal stem cells therapeutic effect, in particular: Fistulas healing efficiency Changes in quality of life in patients treated Changes of systemic Crohn's disease after implant Relapse rate monitored among patients who achieved Adipose-derived mesenchymal Stem Cells treatment success. Achieving the biological characterization of the cell product used and its correlation with the therapeutic effect measured with: Phenotype study Suppressor capacity study. Citoquines production analysis
Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial
Crohn's DiseaseThis multicenter, randomized, controlled trial was conducted by the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the efficacy and safety of the injection of fibrin glue in perianal fistulas tracts of patients with CD. The institutional Independent Ethics Committee of Marseille, France and of Liège, Belgium approved the protocol for each participating centers. Recruitment took place at 12 sites (11 in France and 1 in Belgium)
Managing Inflammatory Bowel Disease
Inflammatory Bowel DiseaseCrohn's Disease1 moreInflammatory Bowel Disease (Crohn's disease and ulcerative colitis) often results in significant life disruption, hospitalization and surgery. While psychosocial factors are not believed to cause IBD, such factors can contribute to the ability of individuals with IBD to cope with the disease, and ineffective coping may lead to the exacerbation of IBD symptoms. The goal of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with IBD. The primary outcomes of interest are IBD symptoms, medical visits, quality of life, and overall disability.
FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR
Inflammatory Bowel DiseaseAnemia4 moreThe purpose of this study is to determine how safe, tolerable and effective the new standardised dosage regimen of FERINJECT® infusions is, compared with a well established intravenous iron treatment.