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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ulcerative Colitis; Inflammatory Bowel Disease (IBD); Acute Severe Ulcerative Colitis
• Intervention / Treatment: Other: Blood sample; Procedure: biopsy

Detailed Description

Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by acute episodes of varying-severity bloody diarrhea. Acute severe colitis poses systemic risks. In our pilot ITAC project, the investigators found a direct link between deep colonic ulcers and systemic inflammation in acute severe colitis, suggesting repair failure. Conversely, excessive repair in UC can lead to colorectal neoplasia, especially sessile serrated adenomas in remission cases.. The investigators plan to prospectively collect tissue and blood samples of patients with UC or non-UC patients with polyps undergoing endoscopy in the Gastroenterology unit or colectomy in the Abdominal surgery unit of CHU de Bordeaux. For all patients, additional biopsies will be collected for histology, microbiota characterization, transcriptomic profiling and cells phenotyping. Additional blood samples will be collected for immune cells phenotyping, genetic profiling, and multiplex cytokines measurement. Routine clinical, endoscopic and biological data will be collected using the Entrepot de Données de Santé of CHU de Bordeaux. The patients will be divided in groups based on the endoscopy phenotype: unactive disease, non-severe active disease, severe disease and on the presence of polyps. Patients without ulcerative colitis with polyps will be studied as a control group.clinical, endoscopic and biological data will be collected using the Entrepot de Données de Santé of CHU de Bordeaux. The patients will be divided in groups based on the endoscopy phenotype: unactive disease, non-severe active disease, severe disease and on the presence of polyps. Patients without ulcerative colitis with polyps will be studied as a control group.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pauline RIVIERE, MD; Phone Number: +335 57 65 64 39; Email: pauline.riviere@chu-bordeaux.fr

Study Locations

• France
  • Pessac, France, 33604
    • CHU de Bordeaux
    • Contact: Pauline RIVIERE, MD; Phone Number: +335 57 65 64 39; Email: pauline.riviere@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• Inclusion criteria:

  • General Inclusion Criteria:

    • Patients covered by a social security system.
    • French-speaking patients.
    • Patients aged ≥18 years.
    • Patients who have provided free, informed, and written consent (no later than the inclusion day and before any research-related examination).

  • Specific Inclusion Criteria for the UC Group:

    • 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.

• Exclusion criteria:

  • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ulcerative Colitis Group	Other: Blood sample; 3 blood samples; Procedure: biopsy; 3 pairs of biopsy realised during the coloscopy
Placebo Comparator: Non-Ulcerative Colitis with Polyps Group	Other: Blood sample; 3 blood samples; Procedure: biopsy; 3 pairs of biopsy realised during the coloscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Pauline RIVIERE, MD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: July 21, 2025
• First Posted (Actual): July 24, 2025

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Biobank; Ulcerative colitis; Inflammatory bowel disease; Acute severe ulcerative colitis
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Ulcer; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: CHUBX 2024/61

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No