MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients

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.

Inclusion Criteria:

- Male or female between 18 and 75 years of age, inclusive;

- With a diagnosis of ileal or ileo-colonic Crohn's disease for a minimum of 3 months
prior to inclusion;

- An ileocolonoscopy scheduled prior to study inclusion;

- Agreeing to participate and to sign an informed consent form;

- Able to perform stool collection, at home, according to protocol;

- Covered by Health Insurance System and/or in compliance with the recommendations of
National Law in force relating to biomedical research.

Exclusion Criteria:

- Colonic Crohn's disease of L2 phenotype based on Montreal classification;

- Extensive small bowel resection (> 100 cm) or short bowel syndrome

- Bowel strictures/stenosis contraindicating ilecolonoscopy;

- Currently with an ostomy or an ileoanal pouch;

- Currently receiving total parenteral nutrition;

- Bowel preparation received in the previous 3 months;

- An increased risk of hemorrhage (patients with anticoagulant/antiplatelet therapy)

- History of intestinal carcinoma and colorectal cancer;

- History or presence of alcohol or substance abuse;

- History of chronic uncontrolled disorders;

- Current participation in an investigational product trial;

- Less than 4 weeks since last participation in a clinical trial;

- Subject inapt or unwilling to participate to the study;

- Pregnant or breastfeeding mother;

- Patient under guardianship.