Cohort of Patients With Ulcerative Colitis or Polyps Followed in CHU de Bordeaux Associated With a Biocollection - COLIBRI

NCT07082231 | Not Yet Recruiting

• 1 other identifier: CHUBX 2024/61
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Ulcerative colitis (UC) is a chronic disease characterized by acute episodes of bloody diarrhea with varying degrees of severity. The most feared event, acute severe UC, can lead to life-threatening and systemic complications. Little is known about the determinants of severity in UC. The investigators hypothesize that distinct severity phenotypes of UC arise from intricated host-microbiota mechanisms influencing repair mechanisms. Our first and main objective is to study the natural history of UC during a one-year time period in a cohort of patients.

Conditions

Ulcerative Colitis; Inflammatory Bowel Disease (IBD); Acute Severe Ulcerative Colitis

Keywords

Acute severe ulcerative colitis; Ulcerative colitis; Inflammatory bowel disease; Biobank

Outcome Measures

Primary Outcomes (6)

• Mayo clinical activity score

  Evolution of Mayo clinical activity score between inclusion and last visit. There is 4 items and for each item is rated from 0 to 3 and total score that varies from 0 to 12

  Baseline, Month 12

• UCEIS endoscopic activity score

  Evolution of UCEIS endoscopic activity score between inclusion and last visit. There is 3 items. Each item is rated from 0 to 2 or 0 to 3 and total score that varies from 0 to 8

  Baseline, Month 12

• Nancy histological activity score

  Evolution of Nancy histological activity score between inclusion and last visit. The Nancy index is defined by a 5-level classification ranging from grade 0 (absence of significant histological disease activity) to grade 4 (severely active disease).

  Baseline, Month 12

• Advanced therapy (biologics or small molecules)

  Number of new advanced therapy (biologics or small molecules) between inclusion visit and last visit

  Baseline, Month 12

• Hospitalization due to disease flare

  Number of hospitalization due to disease flare between inclusion visit and last visit

  Baseline, Month 12

• Colectomy

  Number of colectomy between inclusion and last visit

  Baseline, Month 12

Study Arms (2)

Ulcerative Colitis Group

ACTIVE COMPARATOR

Other: Blood sample; Procedure: biopsy

Non-Ulcerative Colitis with Polyps Group

PLACEBO COMPARATOR

Other: Blood sample; Procedure: biopsy

Interventions

Blood sample OTHER

3 blood samples

Non-Ulcerative Colitis with Polyps Group; Ulcerative Colitis Group

biopsy PROCEDURE

3 pairs of biopsy realised during the coloscopy

Non-Ulcerative Colitis with Polyps Group; Ulcerative Colitis Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients covered by a social security system.
• French-speaking patients.
• Patients aged ≥18 years.
• Patients diagnosed with ulcerative colitis (UC) according to the European Crohn's and Colitis Organisation (ECCO) guidelines.
• Patients undergoing lower gastrointestinal endoscopy or rectocolic surgery.
• Non-UC Patients with Polyps Group:
• Patients undergoing colonoscopy with resection of hyperplastic polyps in the rectum, sessile serrated lesions, or adenomas \>2 cm.

You may not qualify if:

• Patients with perianal, ileal lesions, or endoscopic features of colonic lesions suggestive of Crohn's disease.
• Pregnant or breastfeeding women.
• Patients under legal protection or unable to provide informed consent.
• Patients deprived of liberty by judicial or administrative decision, hospitalized without consent, or admitted to a healthcare or social institution for reasons unrelated to the study.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Pessac, 33604, France

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Blood Specimen Collection; Biopsy

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical

Study Officials

• Pauline RIVIERE, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pauline RIVIERE, MD

CONTACT

+335 57 65 64 39; pauline.riviere@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: July 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)