Digestive Biobank for Exploring Microbiota-host Interactions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Relation between biological parameters and outcomes of digestive disease (IBD, CRC) [Time frame: up to 12 months after the incusion]
Secondary outcome measures (7)
- Relation between biological parameters and outcomes of digestive disease (IBD, CRC) [Time frame: 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]
- Relation between biological parameters and outcomes of digestive disease (IBD, CRC) [Time frame: 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]
- Exploratory study on the physiopathology of host-microbiota interactions to determinate the response to treatments [Time frame: 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]
- Brain-microbiota interaction [Time frame: up to two months after the incusion]
Eligibility criteria
Inclusion criteria
- Ulcerative colitis, Crohn's disease or colorectal disease
- Digestive resection with useless tissue available
- Information consent signed
Exclusion criteria
\- Patients < 18 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Service de Chirurgie Viscérale - Hôpital Saint Antoine — Paris
Identifiers
NCT: NCT05704413 · APHP180540