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Hidden clues in gut tissue may predict ulcerative colitis Flare-Ups

NCT ID NCT07188727

Knowledge-focused Sponsor: IRCCS San Raffaele 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looked at 159 people with ulcerative colitis who started a new advanced therapy. Researchers examined tissue samples from the colon to see if microscopic signs of inflammation could predict future problems like hospital stays or surgery. The goal is to help doctors decide whether to change treatment earlier, even when the colon looks only mildly inflamed during a scope.

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 could help doctors decide when to adjust treatment for ulcerative colitis patients with mild inflammation, potentially preventing worse outcomes.
What could go wrong
This is a small, retrospective study that only looks back at past data, so it cannot prove cause and effect. Results may not apply to all patients.

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.

Participants

159 people

The number who actually took part.

Started

Sep 2019

Finished

May 2025

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.

Who is studied

Adult patients diagnosed with ulcerative colitis who initiated advanced therapy between 2019 and 2025. Patients were stratified according to baseline Mayo Endoscopic Subscore (MES1 or MES2) and had available histologic assessment from endoscopic biopsies.

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: * Confirmed diagnosis of UC (by routine clinical, radiographic, endoscopic and pathologic criteria); * Patients starting a new advanced treatment for UC (either biologic agents or small molecules); * Patients with endoscopic MES of 1 or 2 at the endoscopic reassessment (conducted after 12 ± 3 months following the initiation of advanced therapy) Exclusion Criteria: * Patients with unclassified colitis or Crohn's disease; * Previous colonic surgery (eg. Pouch); * Patients for whom biopsies were not obtained at the time of endoscopic reassessment (conducted after 12 months following the initiation of advanced therapy);

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Ulcerative colitis (UC)

Contacts and locations

Locations

  • IRCCS San Raffaele Hospital

    Milan, MI, 20132, Italy

More trials for these conditions

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