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Gut bacteria may hold key to treating severe colitis

NCT ID NCT04272307

Knowledge-focused Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study investigates whether gut microorganisms and their byproducts play a role in triggering severe flare-ups of ulcerative colitis. Researchers will compare patients hospitalized with severe colitis to those with milder symptoms, analyzing stool and blood samples over three months. The goal is to find biological markers that could help doctors choose the most effective medical therapy and avoid the need for colon removal surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this research could identify biomarkers to guide personalized treatment for severe ulcerative colitis, potentially reducing the need for surgery.
What could go wrong
This is a small early-phase pilot study, so findings may not be definitive or generalizable. The research is observational and does not test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

40 people

The number who actually took part.

Started

May 2020

Finished

Nov 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colitis inflammatory bowel disease ulcer disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colitis Inflammatory bowel diseases Ulcerative

Contacts and locations

Locations

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33076, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.