Date: 2016-09-25
Type of information: Initiation of the trial
phase:
Announcement: initiation of the trial
Company: Enterome Bioscience (France)
Product:
Action mechanism:
Disease: Crohn's Disease
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Country: France, UK, USA
Trial
details: MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients (MOBIDIC) is a multicenter, international descriptive study with a bio-collection in 300 evaluable Crohn's disease patients to be processed after usual biological tests via bioinformatics tools. At this time, this study has no impact neither on treatment nor on disease diagnostic, these will be based on usual medical practices and is no investigational product associated with the conduct of this study. (NCT02882841)
Latest
news: * On August 25, 2016, a Phase 1 trial sponsored by Enterome was published on the NIH website ClinicalTrials.gov for and is currently recruiting participants. 350 Crohn's disease patients will be included in the study, targeting 300 evaluable patients. An interim analysis will be performed after 50% of the evaluable patients are recruited. The primary objective is to evaluate the relation between non-invasive biomarkers (host immunological variables and metagenomic analysis in stools) and Adherent and Invasive Escherichia Coli detection (AIEC) in biopsies taken during an endoscopy, in order to develop a predictive algorithm of AIEC carriage.
