MIcroorganisms as Triggers in Acute Severe Ulcerative Colitis and Their Influence on Medical Ther… (NCT04272307) | Clinical Trial Compass
CompletedEarly Phase 1
MIcroorganisms as Triggers in Acute Severe Ulcerative Colitis and Their Influence on Medical Therapy Efficacy: a Multi-omics Pilot Approach.
France40 participantsStarted 2020-05-14
Plain-language 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 for an ASUC with patients experiencing a Non-Severe Ulcerative Colitis (NSUC) flare by investigating microbiome, metabolome and transcriptome and integrating this data through a multi-omic framework. This systems biology approach aims at enhance our understanding of this severe event, define diagnosis and prognosis biomarkers to improve medical therapy and avoid colectomy and/or death.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.