Crohn Disease, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Brief summary
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.
Detailed description
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).
Interventions
PROCEDUREendoscopic biopsy
Per-endoscopic biopsies
PROCEDUREsamples of the oral cavity
7 samples of the oral cavity with a swab
PROCEDURESamples of the resected specimen
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
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab). | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Post-operative morbidity rates in IBD | 5 years |
| Surgical recurrent rate in Crohn's disease | 5 years |
| Readmission rates for acute severe colitis or ileitis | 5 years |
| Proportion of patients developing a cancer | 5 years |
| Proportion of patients who underwent surgery | 5 years |
| Proportion of patients with a destruction of the intestinal wall in CD (abscess, fistula) | 5 years |
Countries
France
Contacts
Primary ContactAdeline GERMAIN, MD, PhD
Outcome results
None listed