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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07082231
Acronym
COLIBRI
Enrollment
200
Registered
2025-07-24
Start date
2025-09-30
Completion date
2027-09-30
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

OTHERBlood sample

3 blood samples

PROCEDUREbiopsy

3 pairs of biopsy realised during the coloscopy

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Mayo clinical activity scoreBaseline, Month 12Evolution 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
UCEIS endoscopic activity scoreBaseline, Month 12Evolution 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
Nancy histological activity scoreBaseline, Month 12Evolution 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).
Advanced therapy (biologics or small molecules)Baseline, Month 12Number of new advanced therapy (biologics or small molecules) between inclusion visit and last visit
Hospitalization due to disease flareBaseline, Month 12Number of hospitalization due to disease flare between inclusion visit and last visit
ColectomyBaseline, Month 12Number of colectomy between inclusion and last visit

Countries

France

Contacts

Primary ContactPauline RIVIERE, MD
pauline.riviere@chu-bordeaux.fr+335 57 65 64 39

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026