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Stool test may predict gut healing in ulcerative colitis

NCT ID NCT07721441

Knowledge-focused Sponsor: Tang-Du Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study is testing whether a simple stool test can predict if the gut lining is healing in people with moderate-to-severe ulcerative colitis who are starting biologic therapy for the first time. Researchers will measure levels of a protein called calprotectin in stool samples using a new method. The goal is to see if early changes in this protein can tell doctors whether the treatment is working, potentially reducing the need for invasive colonoscopies.

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 test using magnetic particle chemiluminescence
What this could lead to
If successful, this could provide a non-invasive way to predict whether biologic therapy is healing the gut lining in ulcerative colitis, potentially reducing the need for frequent colonoscopies.
What could go wrong
This is an observational study, not a treatment trial, so it will not test a new therapy. The results may not apply to all patients or settings.

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 200 people

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

Started

Jun 2026

Expected to finish

Oct 2027

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

Patients with ulcerative colitis who are aged ≥ 18 years, have moderate-to-severe disease activity, present with disease extent E2 or E3, receive biologic therapy for the first time, and have a confirmed diagnosis of ulcerative colitis for more than 3 months

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 * Aged ≥ 18 years; * Patients with ulcerative colitis receiving initial biologic therapy; * Confirmed diagnosis of ulcerative colitis for more than 3 months; * Moderate-to-severe disease activity; * Disease extent classified as E2 or E3; * Voluntarily signed the informed consent form and agreed to participate in this study. Exclusion Criteria * Aged under 18 years; * Patients who have previously received biologic therapy; * Patients with ulcerative colitis of disease extent E1; * Pregnant or lactating women; * Patients with contraindications to biologic agents; * Patients deemed unsuitable for this clinical study by clinical judgment.

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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)

How to take part

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

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Chongqing General Hospital

    Chongqing, Chongqing Municipality, 401121, China

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044, China

  • Qilu Hospital (Qingdao), Shandong University

    Qingdao, Shandong, 266035, China

  • Shengjing Hospital of China Medical University,

    Shengyang, Liaoning, 110004, China

  • Shenzhen Hospital, Southern Medical University

    Shenzhen, Guangdong, 518101, China

  • Tangdu Hospital, Air Force Medical University

    Xi’an, Shanxi, 710038, China

  • The First Affiliated Hospital of Xi'an Medical University

    Xi’an, Shanxi, 710077, China

  • The Second Hospital of Dalian Medical University

    Dalian, 116023, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • Zhongda Hospital, Southeast University

    Nanjing, Jiangsu, 210009, China

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