Two-Week stool test may forecast ulcerative colitis Flare-Ups a year in advance

NCT ID NCT07111273

Knowledge-focused Sponsor: Qilu Hospital of Shandong University Source: ClinicalTrials.gov ↗

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This study is testing whether changes in two stool markers — a fecal immunochemical test (qFIT) and calprotectin (FC) — measured two weeks after starting standard therapy can predict whether people with ulcerative colitis will relapse or need stronger medication within a year. Researchers will follow 100 adults with active UC who have never taken biologic drugs, collecting stool samples at weeks 0, 2, and 4. The goal is to see if a drop of more than 50% or a return to normal levels in both markers can serve as an early warning sign, helping doctors tailor treatment sooner.

What this could mean

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

Active substance: fecal immunochemical test (qFIT) and fecal calprotectin (FC) measurement
What this could lead to: If early stool marker changes reliably predict relapse, doctors could adjust treatment sooner, potentially preventing flare-ups and reducing the need for stronger drugs.
What could go wrong: This is an observational study, not a treatment trial, so it won't directly improve outcomes. The predictive accuracy may be modest, and results may not apply to all UC patients.

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Study facts

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

Participants

About 100 people

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

Started

Aug 2025

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.

Who is studied

Ulcerative Colitis patints come to clinic or ward of hospitals.

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: * Age 18-75 years. * Established diagnosis of Ulcerative Colitis (UC) confirmed by clinical, endoscopic, and histopathological criteria. * Endoscopic disease activity (Mayo Endoscopic Subscore ≥ 2) confirmed by colonoscopy during screening. * Biologic-naive (no prior exposure to any biologic agent \[e.g., infliximab, adalimumab, vedolizumab, ustekinumab\] or JAK inhibitor). * No use of systemic corticosteroids (oral or intravenous) within 4 weeks prior to Baseline (Week 0) visit. * If using oral or rectal mesalazine/5-ASA preparations, dose must have been stable for ≥2 weeks prior to Baseline (Week 0). Willing and able to provide written informed consent. Exclusion Criteria: * Diagnosis or high suspicion of Crohn's disease, ischemic colitis, infectious colitis, radiation colitis, intestinal tuberculosis, or other types of colitis. Presence of other conditions clearly causing intestinal bleeding (e.g., acute hemorrhoidal bleeding, colorectal cancer, large colorectal polyps \>1cm, intestinal vascular malformations). * Untreated systemic conditions that may cause intestinal bleeding (e.g., thrombocytopenia \[PLT \<50 x 10\^9/L\], severe coagulopathy). * Regular use of antiplatelet agents (e.g., aspirin, clopidogrel) or anticoagulants (e.g., warfarin, rivaroxaban). * Pregnancy or lactation. * Any other condition deemed by the investigator to make the patient unsuitable for study 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.

Biomarker Fecal calprotetin FIT Ulcerative colitis (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

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

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A doctor treating you

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Two-Week stool test may forecast ulcerative colitis Flare-Ups a year in advance

What the study statuses mean