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Stool test strategy aims to prevent UC Flare-Ups

NCT ID NCT07402135

Disease control Sponsor: Qilu Hospital of Shandong University 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tests whether using stool biomarkers (fecal calprotectin and fecal immunochemical test) to guide treatment adjustments can prevent relapses in people with ulcerative colitis. About 240 adults in remission will be randomly assigned to either biomarker-guided therapy or usual care. The goal is to see if early treatment changes based on stool test results can reduce the risk of flare-ups, hospitalizations, or surgery.

What this could mean

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

Active substance
Fecal biomarker-guided therapy escalation (procedure)
What this could lead to
If successful, this approach could help doctors adjust treatment earlier based on stool test results, potentially preventing flare-ups and reducing hospitalizations.
What could go wrong
This is an early-stage strategy trial with no direct treatment benefit. The approach may not improve outcomes over usual care, and the open-label design could introduce bias.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

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 to 75 years

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: 1. Confirmed UC diagnosis ≥6 months. 2. Clinical remission: Partial Mayo Score (pMS) ≤2, with stool frequency and rectal bleeding subscores ≤1. 3. Endoscopic remission (MES ≤1) confirmed by colonoscopy within 12 weeks pre-screening. 4. Stable maintenance therapy (5-ASA, immunomodulators, biologics, or JAK inhibitors) ≥8 weeks. 5. Written informed consent. Exclusion Criteria: 1. Indeterminate colitis or Crohn's disease. 2. History of toxic megacolon, symptomatic colonic stricture, or dysplasia. Prior colectomy. 3. Systemic/local corticosteroid use within 8 weeks. 4. Active gastrointestinal infection or chronic diarrhea from non-UC causes. 5. Pregnancy, lactation, or concurrent interventional trial participation.

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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.

Noninvasive biomarkers Ulcerative colitis (UC)

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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