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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

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 details
    Crohn Disease

NCT06502873

Artialis

15 October 2025

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