Crohn's Disease Clinical Trial
Official title:
MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients (MOBIDIC)
The study 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.
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 AIEC detection in biopsies
taken during an endoscopy, in order to develop a predictive algorithm of AIEC carriage.
The secondary objectives are:
- Validation of the AIEC detection algorithm using qPCR technology.
- Assessment of the correlation between the presence of AIEC and the endoscopic and
clinical evaluations of the disease (CDEIS, SES-CD, Harvey-Bradshaw Index and Crohn's
Disease Activity Index).
- Development and validation of a non-invasive qPCR based diagnostic of Mucosal Healing in
CD patients.
- Collection of biological samples associated with all clinical and biological data from
CD patients.
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