Inflammatory Bowel Disease Cohort in Nantes

Recruiting

• Conditions: Inflammatory Bowel Diseases
• Interventions: Other: Collection of biological samples

• Registration Number: NCT06256393
• Lead Sponsor: Nantes University Hospital

Brief Summary

The CELESTE cohort will be a three-center prospective cohort associated with the creation of a biobank including Inflammatory Bowel Diseases (IBD) patients with active disease

Detailed Description

The CELESTE cohort will be a prospective cohort of IBD patients followed up at Nantes University Hospital, Jules Verne Clinic (Nantes) and/or Confluent Private Hospital (Nantes). The multicentric nature of the cohort including a tertiary referral center and two secondary care centers is a major asset, enabling the enrolment of a broad spectrum of patients, from those naïve to any immunomodulatory treatment to those refractory to multiple biologic therapies.

It will be associated with a multi-omics biobank with the aim of identifying new cellular and molecular signatures of success of the therapeutic strategy at one year.

Study Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-13
• Status Verified: 2025-02
• Study Start: 2025-02-04
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2028-02
• Study Completion: 2031-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Patients over 18 years of age;
• Patients with an established diagnosis of IBD: CD, UC, unclassified IBD or refractory chronic pouchitis;
• Patients with active disease requiring surgery or endoscopy, whether performed at diagnosis or prior to initiation of new therapy;
• Patients who have given written consent to participate in the study and to keep biological samples for research purposes

Exclusion Criteria

• Patients refusing to participate in the cohort;
• Patients with chronic inflammatory bowel disease quiescent at inclusion;
• Patients with a contraindication to general anaesthesia;
• Vulnerable patients (under court protection, curators, guardians);

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Collection of biological samples	Patients of both sexes, over 18 years of age, with an established diagnosis of IBD (Crohn's desease, ulcerative colitis, unclassified IBD or chronic pouchitis) will be eligible for inclusion in a consultation to schedule surgery or colonoscopy for disease relapse (at diagnosis or prior to initiation of treatment), irrespective of treatment received

Primary Outcome Measures

Name	Time	Method
Proportion of patients who succeed in their therapeutic strategy	One year after inclusion	Determine the proportion of patients who succeed in their therapeutic strategy at one year

Trial Locations

Locations (3)

CHU de Nantes; 🇫🇷 Nantes, France

Hopital Privé du Confluent; 🇫🇷 Nantes, France

Clinique Jules Verne; 🇫🇷 Nantes, France