Interventional study of a group of patients with an inflammatory bowel disease (IBD; Crohn's disease (CD) or ulcerative colitis (UC)) to identify predictive and prognostic biomarkers of natural history and response to biotherapies.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Per-endoscopic biopsies
7 samples of the oral cavity with a swab
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
CHRU Nancy
Vandœuvre-lès-Nancy, France
RECRUITINGProportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab).
Time frame: 5 years
Proportion of patients who underwent surgery
Time frame: 5 years
Post-operative morbidity rates in IBD
Time frame: 5 years
Surgical recurrent rate in Crohn's disease
Time frame: 5 years
Proportion of patients with a destruction of the intestinal wall in CD (abscess, fistula)
Time frame: 5 years
Proportion of patients developing a cancer
Time frame: 5 years
Readmission rates for acute severe colitis or ileitis
Time frame: 5 years
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