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

Stopped early · Not applicable

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT02882841

Run by

Enterome

People needed

143

Starts

2016-09-01

Expected to finish

2017-12-01

Last updated by the study team

2018-06-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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