Ulcerative ColitisCOLIBRINCT07082231
Cohort of Patients With Ulcerative Colitis or Polyps Followed in CHU de Bordeaux Associated With a Biocollection - COLIBRI
A study testing Blood sample and biopsy in people with Ulcerative Colitis and Inflammatory Bowel Disease (IBD), run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Disease (IBD), Acute Severe Ulcerative Colitis
- What is being tested?
- Blood sample and biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Bordeaux
Pessac, 33604
Pauline RIVIERE, MD, +335 57 65 64 39, pauline.riviere@chu-bordeaux.fr
About this study
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.
Read the 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.
- Being tested
- Blood sample, biopsy
- Keywords
- Acute severe ulcerative colitis, Ulcerative colitis, Inflammatory bowel disease, Biobank
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
3 blood samples
biopsyProcedure or surgery
3 pairs of biopsy realised during the coloscopy
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative Colitis Group | Active comparator | Not described Receives: Other: Blood sample; Procedure: biopsy |
| Non-Ulcerative Colitis with Polyps Group | Placebo comparator | Not described Receives: Other: Blood sample; Procedure: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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).
Measured: Baseline, Month 12
Advanced therapy (biologics or small molecules)
Number of new advanced therapy (biologics or small molecules) between inclusion visit and last visit
Measured: Baseline, Month 12
Hospitalization due to disease flare
Number of hospitalization due to disease flare between inclusion visit and last visit
Measured: Baseline, Month 12
Colectomy
Number of colectomy between inclusion and last visit
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline RIVIERE, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082231
- Sponsor's protocol ID
- CHUBX 2024/61
- Acronym
- COLIBRI
- Status last verified
- Jul 2025
- First submitted
- 12 Mar 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Patients With Ulcerative Colitis or Polyps Followed in CHU de Bordeaux Associated With a Biocollection - COLIBRI
- ClinicalTrials.gov ID
- NCT07082231
- Acronym / sponsor ID
- COLIBRI / CHUBX 2024/61
- Keywords
- Acute severe ulcerative colitis, Ulcerative colitis, Inflammatory bowel disease, Biobank
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis Group | Active comparator | Other: Blood sample, Procedure: biopsy |
| Non-Ulcerative Colitis with Polyps Group | Placebo comparator | Other: Blood sample, Procedure: biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample3 blood samples | Other | Non-Ulcerative Colitis with Polyps Group, Ulcerative Colitis Group |
| biopsy3 pairs of biopsy realised during the coloscopy | Procedure or surgery | Non-Ulcerative Colitis with Polyps Group, Ulcerative Colitis Group |
Primary outcome
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
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
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).
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
Hospitalization due to disease flare
Time frame: Baseline, Month 12
Number of hospitalization due to disease flare between inclusion visit and last visit
Colectomy
Time frame: Baseline, Month 12
Number of colectomy between inclusion and last visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pauline RIVIERE, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample and biopsy in people with Ulcerative Colitis and Inflammatory Bowel Disease (IBD), run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pauline RIVIERE, MD (+335 57 65 64 39, pauline.riviere@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mayo clinical activity score (time frame: Baseline, Month 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.