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

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.

Study Overview

• Status: Terminated
• Conditions: Crohn's Disease
• Intervention / Treatment: Other: Biopsies, stool and blood collection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Hôpital Saint-Antoine
• United Kingdom
  • London, United Kingdom
    • Guy's and St Thomas' NHS Foundation Trust
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Single-arm study	Other: Biopsies, stool and blood collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary evaluation criterion is the correlation between the detection of AIEC using a non-invasive stool based algorithm and the detection of AIEC using an ileal biopsy taken during an endoscopy.	6-12 months between inclusion and analysis

Collaborators and Investigators

• Sponsor: Enterome
• Collaborators: Eurofins Optimed

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (ESTIMATE): August 30, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: AIEC (Adherent and Invasive Escherichia Coli); Mucosal Healing; Non-invasive biomarkers
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Inflammatory Bowel Diseases; Enterobacteriaceae Infections; Crohn Disease; Escherichia coli Infections
• Other Study ID Numbers: IBD210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO