Clinical trial NCT05704413: Digestive Biobank for Exploring Microbiota-host Interactions
Official title: Digestive Biobank for Exploring Microbiota-host Interactions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Colorectal Cancer
Indeterminate Colitis
Keywords: Microbiota
inflammatory bowel disease
Crohn's disease
ulcerative colitis
colorectal cancer
post-operative cognitive disorders
mood disorders
immune system.
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Relation between biological parameters and outcomes of digestive disease (IBD, CRC)
timeFrame: up to 12 months after the incusion
Secondary outcomes:
measure: Relation between biological parameters and outcomes of digestive disease (IBD, CRC)
timeFrame: up to 12 months after the incusion
measure: Relation between biological parameters and outcomes of digestive disease (IBD, CRC)
timeFrame: up to 12 months after the incusion
measure: Relation between biological parameters and outcomes of digestive disease (IBD, CRC)
timeFrame: up to 12 months after the incusion
measure: Exploratory study on the physiopathology of host-microbiota interactions to determinate the occurrence of intestinal and extra-intestinal complications
timeFrame: up to two months after the incusion
measure: Exploratory study on the physiopathology of host-microbiota interactions to determinate the response to treatments
timeFrame: up to two months after the incusion
measure: Exploratory study on the physiopathology of host-microbiota interactions
timeFrame: up to two months after the incusion
measure: Brain-microbiota interaction
timeFrame: up to two months after the incusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Chirurgie Viscérale - Hôpital Saint Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jérémie LEFEVRE, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: