Stool Calprotectin Test to Predict Gut Healing in Ulcerative Colitis on a First Biologic
Studies whether an early stool calprotectin test predicts healing in adults with ulcerative colitis.
Plain-language title generated from the registry record
Registry title: Predictive Efficacy of Fecal Calprotectin Assay by Magnetic Particle Chemiluminescence for Mucosal Healing in Moderate-to-Severe Ulcerative Colitis Patients Undergoing Initial Biologic Therapy（PRECAL）
Key facts
- Where
- Beijing, Chongqing, Dalian, Nanjing, Qingdao, Shengyang, Shenzhen, Wuhan, and Xi'an, ChinaSee the 10 sites
Where in China
- Peking University People's HospitalBeijing, ChinaNo longer taking part
- Chongqing General HospitalChongqing, ChinaNo longer taking part
- The Second Hospital of Dalian Medical UniversityDalian, ChinaNo longer taking part
- Zhongda Hospital Southeast UniversityNanjing, ChinaNo longer taking part
- Qilu Hospital (Qingdao), Shandong UniversityQingdao, ChinaNo longer taking part
- Shengjing Hospital of China Medical UniversityShengyang, ChinaNo longer taking part
- Shenzhen Hospital, Southern Medical UniversityShenzhen, ChinaNo longer taking part
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaNo longer taking part
- Tangdu Hospital, Air Force Medical UniversityXi'an, ChinaNo longer taking part
- The First Affiliated Hospital of Xi'an Medical UniversityXi'an, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tang-Du Hospital
- Trial code
- NCT07721441
- Record updated
- 23 July 2026
- Original description
This is a national prospective, multicenter, observational study. A total of 200 eligible patients will be enrolled from 10 hospitals across the country. Inclusion criteria are as follows: aged ≥ 18 years; diagnosed with moderate-to-severe active ulcerative colitis (UC); disease extent classified as E2 or E3; receiving biologic therapy for the first time; and having a confirmed UC diagnosis for more than 3 months. The follow-up period lasts 30-32 weeks. Six scheduled follow-up visits will be conducted at baseline, weeks 2-4, 6-8, 14-16, 22-24, and 30-32 after enrollment. The study endpoints are defined as: endoscopic mucosal healing (Mayo endoscopic score = 0 for UC), clinical judgment of inadequate response to current biologic therapy (i.e., continued treatment is unlikely to achieve mucosal healing and thus treatment switching or combined medication is required), or completion of the 30-32-week follow-up. The primary objective is to determine the cutoff value and predictive efficacy of the early (Weeks 2-4) reduction in fecal calprotectin (FC) measured by magnetic particle chemiluminescence assay for predicting mucosal healing in moderate-to-severe UC patients initiating biologic therapy.Read full original descriptionShow less
Predictive Efficacy of Fecal Calprotectin Assay by Magnetic Particle Chemiluminescence for Mucosal Healing in Moderate-to-Severe Ulcerative Colitis Patients Undergoing Initial Biologic Therapy: A Prospective, Multicenter, Observational Clinical Study
This is a national prospective, multicenter, observational study. A total of 200 eligible patients will be enrolled from 10 hospitals across the country. Inclusion criteria are as follows: aged ≥ 18 years; diagnosed with moderate-to-severe active ulcerative colitis (UC); disease extent classified as E2 or E3; receiving biologic therapy for the first time; and having a confirmed UC diagnosis for more than 3 months. The follow-up period lasts 30-32 weeks. Six scheduled follow-up visits will be conducted at baseline, weeks 2-4, 6-8, 14-16, 22-24, and 30-32 after enrollment. The study endpoints are defined as: endoscopic mucosal healing (Mayo endoscopic score = 0 for UC), clinical judgment of inadequate response to current biologic therapy (i.e., continued treatment is unlikely to achieve mucosal healing and thus treatment switching or combined medication is required), or completion of the 30-32-week follow-up. The primary objective is to determine the cutoff value and predictive efficacy of the early (Weeks 2-4) reduction in fecal calprotectin (FC) measured by magnetic particle chemiluminescence assay for predicting mucosal healing in moderate-to-severe UC patients initiating biologic therapy.
Inclusion: 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: Patients who have previously received biologic therapy; Patients with ulcerative colitis of disease extent E1; Aged under 18 years; Pregnant or lactating women; Patients with contraindications to biologic agents; Patients deemed unsuitable for this clinical study by clinical judgment.