Ulcerative Colitis (UC)FORESEE-UCNCT07111572
Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis
An observational study of Ulcerative Colitis (UC) and Fecal Calprotetin, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This multicenter prospective cohort aims to evaluate whether combined changes in fecal calprotectin (FC) and fecal immunochemical test (FIT) at Week 2 and Week 4 after initiating biologic therapy (vedolizumab or infliximab) can predict clinical response at Week 14 and mucosal healing at Week 52 in moderate-to-severe… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis (UC), Fecal Calprotetin, FIT
- What is being tested?
- fecal calprotectin
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: UC patinets accept biologics
Who may be able to join
- 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
Who cannot join
- Pregnancy/lactation
- Contraindications to biologics (e.g., active TB, severe infection)
- Experimental drug use within 4 weeks prior to baseline
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 251400
Yan Zhang, M.D., +86 18560089821, qlzhangyan@sdu.edu.cn
About this study
Official title: Dynamic Changes of Fecal Calprotectin and Fecal Immunochemical Test for Early Prediction of Biologic Treatment Efficacy in Ulcerative Colitis: A Multicenter, Prospective Cohort Study
This multicenter prospective cohort aims to evaluate whether combined changes in fecal calprotectin (FC) and fecal immunochemical test (FIT) at Week 2 and Week 4 after initiating biologic therapy (vedolizumab or infliximab) can predict clinical response at Week 14 and mucosal healing at Week 52 in moderate-to-severe ulcerative colitis (UC) patients. Primary outcome: clinical remission rate at Week 14.
- Conditions
- Ulcerative Colitis (UC), Fecal Calprotetin, FIT
- Being tested
- fecal calprotectin
- Keywords
- UC, fecal calprotectin, FIT
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal calprotectinDiagnostic test
patients will accpet test of FC combine FIT
| Study group | Role | What they receive |
|---|---|---|
| UC patients accept therapy of biologics | Not described Receives: Diagnostic Test: fecal calprotectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion achieving **clinical remission** (Full Mayo Score ≤2, no subscore >1) at **Week 14**
Measured: WEEK 14
Secondary outcomes (1)
Mucosal healing (MES=0) at W52
Clinical response rate (W14)
- Endoscopic improvement (MES ≤1) at W14
- Steroid-free clinical remission at W52
- Mucosal healing (MES=0) at W52
- ROC analysis of FC/FIT for predicting outcome
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University (Qingdao), Dezhou Hospital Qilu Hospital of Shandong University, Weihai Municipal Hospital, Liaocheng People's Hospital, Jining First People's Hospital
- Responsible party
- Principal investigator, Yan Zhang, MD, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111572
- Sponsor's protocol ID
- QILUGI-003
- Acronym
- FORESEE-UC
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes of Fecal Calprotectin and Fecal Immunochemical Test for Early Prediction of Biologic Treatment Efficacy in Ulcerative Colitis: A Multicenter, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07111572
- Acronym / sponsor ID
- FORESEE-UC / QILUGI-003
- Conditions
- Ulcerative Colitis (UC), Fecal Calprotetin, FIT
- Keywords
- UC, fecal calprotectin, FIT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University (Qingdao), Dezhou Hospital Qilu Hospital of Shandong University, Weihai Municipal Hospital, Liaocheng People's Hospital, Jining First People's Hospital
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter prospective cohort aims to evaluate whether combined changes in fecal calprotectin (FC) and fecal immunochemical test (FIT) at Week 2 and Week 4 after initiating biologic therapy (vedolizumab or infliximab) can predict clinical response at Week 14 and mucosal healing at Week 52 in moderate-to-severe ulcerative colitis (UC) patients. Primary outcome: clinical remission rate at Week 14.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UC patients accept therapy of biologics | – | Diagnostic Test: fecal calprotectin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UC patinets accept biologics
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy/lactation
- Contraindications to biologics (e.g., active TB, severe infection)
- Experimental drug use within 4 weeks prior to baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fecal calprotectinpatients will accpet test of FC combine FIT | Diagnostic test | UC patients accept therapy of biologics |
Primary outcome
Proportion achieving clinical remission (Full Mayo Score ≤2, no subscore >1) at Week 14
Time frame: WEEK 14
1 secondary outcome
Mucosal healing (MES=0) at W52
Time frame: week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis (UC) and Fecal Calprotetin, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Zhang, M.D (+86 18560089821, qlzhangyan@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion achieving clinical remission (Full Mayo Score ≤2, no subscore >1) at Week 14 (time frame: WEEK 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.