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NCT Number: NCT07082231

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

blood sample

Other

3 blood samples

Biopsy

Procedure

3 pairs of biopsy realised during the coloscopy

Primary outcomes

  1. Mayo clinical activity score

    Time frame: Baseline, Month 12

    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

  2. UCEIS endoscopic activity score

    Time frame: Baseline, Month 12

    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

  3. Nancy histological activity score

    Time frame: Baseline, Month 12

    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).

  4. Advanced therapy (biologics or small molecules)

    Time frame: Baseline, Month 12

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

  5. Hospitalization due to disease flare

    Time frame: Baseline, Month 12

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

  6. Colectomy

    Time frame: Baseline, Month 12

    Number of colectomy between inclusion and last visit

Study contacts

Contact information is provided by the study sponsor or research team.

Pauline RIVIERE, MD

CONTACT

[email protected]

+335 57 65 64 39

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: COLIBRI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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