Status:
RECRUITING
Setting up a Cohort of Patients With Crohn's Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease
Lead Sponsor:
Artialis
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to constitute cohorts of Crohn versus non-Crohn patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with Crohn disease, and develop a prototype ...
Eligibility Criteria
Inclusion
- 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 CD
- 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
- Specific for Control cohort:
- Patient with no colonic lesion(s) visible during the endoscopical examination (neither Crohn's nor other colitis nor cancer)
Exclusion
- 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,…)
Key Trial Info
Start Date :
June 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06502873
Start Date
June 28 2024
End Date
February 28 2026
Last Update
July 16 2024
Active Locations (1)
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1
CHU de Liège
Liège, Belgium