Inflammatory Bowel Disease (IBD)
Conditions
Keywords
cohort, BEV, intestinal dysbiosis
Brief summary
The objective of this study is to constitute cohorts of IBD versus non-IBD patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with inflammatory bowel disease, and develop a prototype for assaying such marker(s) in blood.
Interventions
PROCEDUREbiological samples collection
Collection of biological samples from the same cohorts: faeces, serum, intestinal biopsies
Sponsors
Artialis
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Prospective, monocentric, study aiming to recruit 2 types of patients (60 inflammatory bowel disease (IBD) suffering patients versus 60 control patients without IBD nor any other known intestinal pathology).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General criteria: * Male or female ≥ 18 years old * Able to follow the instructions of the study * Having signed an informed consent Specific for Crohn cohort: * A confirmed diagnosis of IBD * Rectal or colonic or ileocolic involvement * Patients with CD presenting inflammatory flare and disease extent in the colon or ileocolic region with: * A clinical activity defined by an average of four or more instances of very soft or liquid stools daily or an abdominal pain score of 2 or more OR a CDAI (CD Activity Index) ≥ 220 OR a Harvey-Bradshaw Index \> 8 OR a faecal calprotectin ≥ 250 µg/g And * A endoscopic activity defined by a SES-CD (Simple Endoscopic Score for Crohn Disease) ≥ 6 or a CDEIS (CD Endoscopic Index score) ≥ 7 * Patients with UC presenting inflammatory flare with: A clinical activity defined by a modified Mayo score ≥ 3 OR a Simple Clinical Colitis Activity Index ≥5 OR Patient Reported Outcome (PRO2) ≥ 4 with a subscore of rectal bleeding ≥1 OR a faecal calprotectin ≥ 250 µg/g AND An endoscopic activity defined by a Mayo endoscopic sub-score ≥ 2 Specific for Control cohort: Patient with no colonic lesion(s) visible during the endoscopical examination (neither Crohn's nor other colitis nor cancer)
Exclusion criteria
General criteria: * Commercial Pharmaceutical probiotic administration within the previous month * Treatment with antibiotics (whatever the route of administration) within last 3 months * Non-remission Cancer or in remission for less than 6 months * Any contraindication to colonoscopy and/or biopsy, left to PI discretion * Under guardianship or judiciable protection * Pregnant or breastfeeding women * Currently participating or having participated in the last 3 months to a clinical study with investigational medicine or food supplement Specific for Crohn cohort: * Crohn disease localized only in Ileum * Inflammatory colon pathology other than Crohn's (infectious, drug-induced,…)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients recruited in each cohort | 27 months | 60 patients in IBD cohort and 60 patients in control cohort |
| number of faeces samples collected in each cohort | 27 months | 60 patients in IBD cohort and 60 patients in control cohort |
| Number of plasma samples collected in each cohort | 27 months | 60 patients in IBD cohort and 60 patients in control cohort |
| Number of biopsy samples collected in each cohort | 27 months | 60 patients in IBD cohort and 60 patients in control cohort with 4 colonic biopsies/ patient |
Countries
Belgium
Contacts
CONTACTBérénice Costes
PRINCIPAL_INVESTIGATORCatherine Van Kemseke, MD
Centre Hospitalier Universitaire de Liege
Outcome results
None listed