Setting up a Cohort of Patients With Crohn's Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease

Not Applicable

Recruiting

• Conditions: Crohn Disease
• Interventions: Procedure: biological samples collection

• Registration Number: NCT06502873
• Lead Sponsor: Artialis

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 for assaying such marker(s) in blood.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-28
• Status Verified: 2024-07
• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Study First Posted: 2024-07-16
• Last Update Posted: 2024-07-16
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 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 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,...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crohn disease cohort	biological samples collection	60 patients diagnosed with colonic or ileocolic Crohn disease
Control cohort	biological samples collection	60 control patients without inflammatory bowel diseases

Primary Outcome Measures

Name	Time	Method
number of faeces samples collected in each cohort	18 months	60 patients in crohn cohort and 60 patients in control cohort
Number of plasma samples collected in each cohort	18 months	60 patients in crohn cohort and 60 patients in control cohort
Number of biopsy samples collected in each cohort	18 months	60 patients in crohn cohort and 60 patients in control cohort with 4 colonic biopsies/ patient
Number of patients recruited in each cohort	18 months	60 patients in crohn cohort and 60 patients in control cohort

Trial Locations

Locations (1)

CHU de Liège; 🇧🇪 Liège, Belgium