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Recruiting NCT06502873

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

Trial Parameters

Condition Inflammatory Bowel Disease (IBD)
Sponsor Artialis
Study Type INTERVENTIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-06-28
Completion 2026-09-30
Interventions
biological samples collection

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.

Eligibility Criteria

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

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