Digestive Biobank for Exploring Microbiota-host Interactions (BiomHost)

January 19, 2023 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75012
        • Recruiting
        • Service de Chirurgie Viscérale - Hôpital Saint Antoine
        • Sub-Investigator:
          • Franck Verdonk, MD, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients older than 18 years-old. With an Ulcerative colitis, Crohn's Disease or colorectal cancer Operated in the Departement of digestive surgery of Saint-Antoine Hospital After signature of the information consent

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Patients < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
digestive cancer or IBD
Patient with digestive cancer or IBD having surgery with intestinal resection planned in the Visceral Surgery Department of St Antoine Hospital

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jérémie LEFEVRE, PU-PH, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2021

Primary Completion (Anticipated)

September 17, 2026

Study Completion (Anticipated)

September 17, 2026

Study Registration Dates

First Submitted

February 18, 2019

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Estimate)

January 30, 2023

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP180540

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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