IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE

Study Overview
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Brief Summary
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Interventional study of a group of patients with an inflammatory bowel disease (Crohn's disease or ulcerative colitis) to identify predictive and prognostic biomarkers of natural history and response to biotherapies.

Detailed Description
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Percentage of primary responders who haven't lost response to biotherapies during follow-up (anti-TNF, ustekinumab, vedolizumab). Response to treatment will be evaluated using objective criteria for measuring intestinal inflammation: endoscopic remission (endoscopic biopsy and surgical specimens), radiological (MRI), and / or biological (CRP, fecal calprotectin) . Response to therapy rates will be correlated with genomic, epigenomic, and microbiota data stratified by major environmental factors (nutrition, tobacco, physical activity).

Official Title
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IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS OF NATURAL HISTORY AND RESPONSE TO BIOTHERAPIES IN INFLAMMATORY BOWEL DISEASE : i-BANK

Conditions
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Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis

Intervention / Treatment
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* Procedure: endoscopic biopsy
* Procedure: samples of the oral cavity
* Procedure: Samples of the resected specimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>=18 years Patients with an established diagnosis of CD or UC (clinical, biological, radiological, endoscopic or histologic criteria) Patients >=45 kg Affiliated member of the Social Security system Exclusion Criteria: Patients with an undetermined colitis Patients with a non established diagnosis of CD Women of childbearing age without a method of contraception Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code Pregnant women, breastfeeding women -- Age < 18 years Persons under legal protection Person who does not have the capacity to consent Persons under the age of 18 years who are deprived of their liberty by decision of a judicial or administrative authority (articles L. 3212-1 and L. 3213-1).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IBD patients<br>All patients with an established Crohn's disease or ulcerative colitis | Procedure: endoscopic biopsy<br>* Per-endoscopic biopsies<br>Procedure: samples of the oral cavity<br>* 7 samples of the oral cavity with a swab<br>Procedure: Samples of the resected specimen<br>* if patient has to undergo a digestive resection as part of his standard management, samples of the pathological area and samples at the end of the resection will be realised<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab). |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who underwent surgery |  | 5 years | 
| Post-operative morbidity rates in IBD |  | 5 years | 
| Surgical recurrent rate in Crohn's disease |  | 5 years | 
| Propotion of patients with a destruction of the intestinal wall in CD (abscess, fistula) |  | 5 years | 
| Proportion of patients developing a cancer |  | 5 years | 
| Readmission rates for acute severe colitis or ileitis |  | 5 years |