Status:
UNKNOWN
MIcroorganisms as Triggers in Acute Severe Ulcerative Colitis and Their Influence on Medical Therapy Efficacy: a Multi-omics Pilot Approach.
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Inflammatory Bowel Diseases
Colitis
Eligibility:
All Genders
18+ years
Brief Summary
This pilot prospective study will investigate the role of microbiota and known enteropathogens in Acute Severe Ulcerative Colitis (ASUC). Investigators will compare a group of patients hospitalized fo...
Detailed Description
Ulcerative Colitis (UC) is one of the two entities of Inflammatory Bowel Disease (IBD), along with Crohn's disease. One in 4 patients experiences an Acute Severe Ulcerative Colitis (ASUC) during the d...
Eligibility Criteria
Inclusion
- All patients:
- Adult patients diagnosed with Ulcerative Colitis according to usual criteria.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
- ASUC group:
- Adult patients hospitalized an ASUC defined according to Truelove criteria, i.e. ≥6 bloody daily stools with one or more of the following criteria: temperature \>37.8°C, pulse \>90 beats/min, haemoglobin \<10.5g/dl or C Reactive-Protein \>45mg/l.
- Non severe acute UC patients (NSUC) group:
- Adult patients with disease activity symptoms, corresponding to a partial Mayo score of 4 or more with a rectal bleeding subscore of at least 1, without Truelove severity criteria.
Exclusion
- Patients with perianal lesions, ileal lesions or endoscopic aspect of the colonic lesions related to a Crohn's disease acute severe colitis.
- Patients under 18 years old.
- Patients under legal protection or unable to express their consent.
- Patients not affiliated to a health insurance system.
- Patients deprived of liberty by judiciary or administrative decision or hospitalized without consent or admitted in a sanitary or social institution for another reason than research
Key Trial Info
Start Date :
May 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04272307
Start Date
May 14 2020
End Date
February 1 2022
Last Update
May 26 2020
Active Locations (1)
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1
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France, 33076