MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's… (NCT02882841) | Clinical Trial Compass
TerminatedNot Applicable
MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients
Stopped: Poor accrual
United States, France, United Kingdom143 participantsStarted 2016-09
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: 6-12 months between inclusion and analysis