UCRecruiting

DYNAMIC-UC: Early qFIT and Calprotectin Change Predicting Relapse in Biologic-Naive Ulcerative Colitis

Observational · No treatment assigned · 1 site · Qilu Hospital of Shandong University

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

Condition(s) listed: Ulcerative Colitis (UC), Fecal Calprotetin and FIT. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

Ages 18 to 75
Any sex

Some of the main requirements, copied from the record:

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.

Plus 4 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 100 participants are expected to take part.
Start date: 2025-08-01.
Main results expected around 2026-08-31 (estimate from the record).
1 study site listed (1 marked recruiting) in China.

Main thing being measured

Composite Endpoint Rate (Clinical Relapse OR Treatment Escalation) (From enrollment to Week 52 (±2 weeks))

In the researchers’ words

This multicenter prospective cohort study aims to evaluate whether a >50% decrease or normalization of both quantitative fecal immunochemical test (qFIT) and fecal calprotectin (FC) levels at 2 weeks after starting conventional therapy (mesalazine or corticosteroids) can predict clinical relapse or need for biologic/JAK inhibitor therapy escalation by 52 weeks in biologic-naive patients with active ulcerative…

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Observational
Study type	Observational
Conditions	Ulcerative Colitis (UC); Fecal Calprotetin; FIT; Biomarker
Lead sponsor	Qilu Hospital of Shandong University
Collaborators	Qilu Hospital of Shandong University (Qingdao); Dezhou Hospital Qilu Hospital of Shandong University; JiNing NO.1 People Hospital; Zaozhuang Municipal Hospital; caoxian chinese medicine hospital; longkou chinsese medicine hospital; Shouguang People's Hospital; Weihai Municipal Hospital; Liaocheng People's Hospital; ZhangQiu Yile Hospital
Enrollment	100 (estimated)
Start date	2025-08-01
Primary completion (est.)	2026-08-31
First posted	2025-08-08
Last updated	2026-07-28
Official title	Diagnostic Value of Quantitative Fecal Immunochemical Test (qFIT) and Calprotectin (FC) Dynamic Changes at 2 Weeks for Predicting 52-Week Relapse or Treatment Escalation in Biologic-Naive Ulcerative Colitis: A Multicenter, Prospective Cohort Study (DYNAMIC-UC)
ClinicalTrials.gov ID	NCT07111273

Interventions

FC and FIT TEST at WEEK0 2 4 (Diagnostic Test)
FC and FIT TEST at WEEK0 2 4

Full eligibility criteria (from the record)

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.

Locations (1)

Site	City	Country	Site status
Shandong University	Jinan, Shandong	China	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.