Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease
Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease in the Context of the Translational Study of Biomarkers of Intestinal Dysbiosis (ELITE Walloon Project)
Artialis
120 participants
Jun 28, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria14
- 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 Criteria11
- 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,…)
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Interventions
Collection of biological samples from the same cohorts: faeces, serum, intestinal biopsies
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06502873