Digestive Biobank for Exploring Microbiota-host Interactions

Recruiting

• Conditions: Crohn Disease; Inflammatory Bowel Diseases; Colorectal Cancer; Ulcerative Colitis; Indeterminate Colitis

• Registration Number: NCT05704413
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Constitution of a biobank of tissues, whole blood and plasma samples and stools to identify markers associated with treatment response, postoperative morbidity including neuro-cognitive and mood complications and prognosis of Inflammatory Bowel disease or colorectal cancer.

Detailed Description

Inflammatory Bowel disease (Crohn, Ulcerative colitis) and colorectal cancer are frequent affections and the microbiota plays a major role in their physiopathology involving the immune system. In this setting, the interplay between gut microbiota and brain is still unexplored.

To evaluate the interaction of the microbiota and the immune system with the host in these two chronic diseases, we aim to create a prospective biobank.

A small amount of tissue will be taken during surgery. A whole blood, plasma and stoll samples will also be taken from the patient.

All samples will be anonymized.

Study Timeline

• Study First Submitted: 2019-02-18
• Study Start: 2021-06-17
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-19
• Last Update Submitted: 2023-01-19
• Study First Posted: 2023-01-30
• Last Update Posted: 2023-01-30
• Primary Completion: 2026-09-17
• Study Completion: 2026-09-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Ulcerative colitis, Crohn's disease or colorectal disease
• Digestive resection with useless tissue available
• Information consent signed

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Exclusion Criteria

• Patients < 18 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relation between biological parameters and outcomes of digestive disease (IBD, CRC)	up to 12 months after the incusion	identify relations between serumon response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.

Secondary Outcome Measures

Name	Time	Method
Relation between biological parameters and outcomes of digestive disease (IBD, CRC)	up to 12 months after the incusion	identify relations between faeces) on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.
Exploratory study on the physiopathology of host-microbiota interactions to determinate the response to treatments	up to two months after the incusion	genetic polymorphisms, serum markers, intestinal microbiota markers determining : response to treatments
Exploratory study on the physiopathology of host-microbiota interactions to determinate the occurrence of intestinal and extra-intestinal complications	up to two months after the incusion	genetic polymorphisms, serum markers, intestinal microbiota markers to determining the occurrence of intestinal and extra-intestinal complications
Exploratory study on the physiopathology of host-microbiota interactions	up to two months after the incusion	genetic polymorphisms, serum markers, intestinal microbiota markers determining : interactions between host and microbiota
Brain-microbiota interaction	up to two months after the incusion	Exploring the pathophysiology of host-microbiota interactions in postoperative cognitive or behavioral changes involving inflammation pathways

Trial Locations

Locations (1)

Service de Chirurgie Viscérale - Hôpital Saint Antoine; 🇫🇷 Paris, France