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

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Aug 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether early changes in two stool tests—called qFIT and fecal calprotectin—can help predict if people with active ulcerative colitis (a long-term bowel condition) will have a flare-up or need stronger medicine within one year. The researchers want to see if a big drop or return to normal levels in these tests, just two weeks after starting usual treatment (like mesalazine or steroids), can indicate how well a patient is doing and if more advanced treatments might be needed later.

Adults aged 18 to 75 with confirmed ulcerative colitis who have not used biologic medicines or similar drugs before may be eligible. To join, patients must have active inflammation confirmed by a colonoscopy and should not have used steroids recently. During the study, patients will provide stool samples at the start, then at two and four weeks, but the results won’t be shared with doctors or patients until the study ends. This helps researchers understand how early test changes relate to long-term outcomes without influencing treatment decisions. The trial is not yet recruiting, but if you qualify, you can expect to continue your usual care while helping researchers learn more about managing ulcerative colitis.

Gender

ALL

Eligibility criteria

• 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.