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

ConditionsUlcerative ColitisInflammatory Bowel Disease (IBD)Acute Severe Ulcerative Colitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood sample

    Other intervention

    3 blood samples

  • biopsy

    Procedure/Surgery

    3 pairs of biopsy realised during the coloscopy

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Ulcerative Colitis GroupActive comparator 2 interventions
Group B: Non-Ulcerative Colitis with Polyps GroupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, Month 12
2

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

Time frame
Baseline, Month 12
3

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).

Time frame
Baseline, Month 12
4

Advanced therapy (biologics or small molecules)

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

Time frame
Baseline, Month 12

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bordeaux

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: