Digestive Biobank for Exploring Microbiota-host Interactions

Study Overview
=================
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.

Official Title
-----------------
Digestive Biobank for Exploring Microbiota-host Interactions

Conditions
-----------------
Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Colorectal Cancer, Indeterminate Colitis

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| digestive cancer or IBD<br>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) | 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) | 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) | 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) | 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 | 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 | 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 | genetic polymorphisms, serum markers, intestinal microbiota markers determining : interactions between host and microbiota | up to two months after the incusion | 
| Brain-microbiota interaction | Exploring the pathophysiology of host-microbiota interactions in postoperative cognitive or behavioral changes involving inflammation pathways | up to two months after the incusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microbiota, inflammatory bowel disease, Crohn's disease, ulcerative colitis, colorectal cancer, post-operative cognitive disorders, mood disorders, immune system.