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Stool tests may predict biologic success in ulcerative colitis within weeks

NCT ID NCT07111572

Diagnosis 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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This study is testing whether two simple stool tests—fecal calprotectin and a fecal immunochemical test (FIT)—can predict early on if biologic therapy will help people with moderate-to-severe ulcerative colitis. Researchers will measure these markers at weeks 2 and 4 after starting treatment with vedolizumab or infliximab, then check if patients achieve remission by week 14 and healing of the gut lining by week 52. The goal is to find a non-invasive way to quickly tell if a treatment is working, potentially saving patients from months of ineffective therapy.

What this could mean

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

Active substance
fecal calprotectin and fecal immunochemical test (FIT) as diagnostic tests
What this could lead to
If successful, this could allow doctors to predict early whether a biologic drug is working for ulcerative colitis, helping patients avoid months of ineffective treatment.
What could go wrong
This is an observational study, not a treatment trial. The tests may not be accurate enough to replace standard monitoring, and 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

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

UC patinets accept biologics

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, UC diagnosis with endoscopic Mayo score (MES) ≥2 * Moderate-to-severe activity (Full Mayo Score ≥6) * Initiating vedolizumab or infliximab within 7 days after baseline * Biologic-naïve or prior exposure to only one TNF-α inhibitor \*\*Exclusion Criteria:\*\* * Pregnancy/lactation * Contraindications to biologics (e.g., active TB, severe infection) * Experimental drug use within 4 weeks prior to baseline

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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.

Fecal calprotetin FIT Ulcerative colitis (UC)

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 251400, China

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