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

NCT02882841 | Terminated

• 1 other identifier: IBD210
• Study Type: interventional
• Target: 143
• Locations: 3 countries
• Sites: 3

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.

Conditions

Crohn's Disease

Keywords

AIEC (Adherent and Invasive Escherichia Coli); Mucosal Healing; Non-invasive biomarkers

Outcome Measures

Primary Outcomes (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.

  6-12 months between inclusion and analysis

Study Arms (1)

Single-arm study

OTHER

Other: Biopsies, stool and blood collection

Interventions

Biopsies, stool and blood collection OTHER

Single-arm study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Enterome: lead
• Eurofins Optimed: collaborator

Study Sites (3)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Hôpital Saint-Antoine

Paris, France

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Biopsy; Defecation

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 12, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); FR (1); GB (1)