Back to resultsMOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients (MOBIDIC)
Primary Purpose
Crohn's Disease
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Biopsies, stool and blood collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Crohn's Disease focused on measuring AIEC (Adherent and Invasive Escherichia Coli), Mucosal Healing, Non-invasive biomarkers
Eligibility Criteria
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.
Sites / Locations
- Children's Hospital Boston
- Hôpital Saint-Antoine
- Guy's and St Thomas' NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single-arm study
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02882841
First Posted
August 25, 2016
Last Updated
June 11, 2018
Sponsor
Enterome
Collaborators
Eurofins Optimed
1. Study Identification
Unique Protocol Identification Number
NCT02882841
Brief Title
MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients
Acronym
MOBIDIC
Official Title
MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients (MOBIDIC)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enterome
Collaborators
Eurofins Optimed
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
AIEC (Adherent and Invasive Escherichia Coli), Mucosal Healing, Non-invasive biomarkers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-arm study
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Biopsies, stool and blood collection
Primary Outcome Measure Information:
Title
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.
Time Frame
6-12 months between inclusion and analysis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Hôpital Saint-Antoine
City
Paris
Country
France
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients
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