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A Randomized Controlled Study Comparing the Impact of Fecal Calprotectin Alone versus Combined Fecal Calprotectin and Intestinal Ultrasound on Treatment Decisions for Patients with Mild to Moderate Active Ulcerative Colitis

A Randomized Controlled Study Comparing the Impact of Fecal Calprotectin Alone versus Combined Fecal Calprotectin and Intestinal Ultrasound on Treatment Decisions for Patients with Mild to Moderate Active Ulcerative Colitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124016
Enrollment
Unknown
Registered
2026-05-06
Start date
2025-12-03
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Interventions

FC Group (Fecal Calprotectin Guided Group):1. Induction phase: Mesalazine 4g/day for 4 weeks. 2. Escalation therapy (if target achieved): Corticosteroids, immunosuppressants, biologics/small molecule
FC+IUS Group (Fecal Calprotectin + Intestinal Ultrasound Guided Group):1. Induction phase: Mesalazine 4g/day for 4 weeks. 2. Escalation therapy (if target achieved): Corticosteroids, immunosuppressant

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older. 2. Diagnosed with ulcerative colitis (UC) based on the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi’an), through comprehensive assessment of clinical presentation, laboratory tests, imaging, endoscopy, and histopathology, after excluding infectious and other non-infectious colitis. Disease activity must be mild to moderate according to the modified Mayo score (range 3–10: 3–5 = mild, 6–10 = moderate, 11–12 = severe). 3. Montreal classification: left-sided colitis (E2) or extensive colitis (E3).

Exclusion criteria

Exclusion criteria: 1. Diagnosis of indeterminate colitis. 2. Pregnancy, lactation, or planned pregnancy in female patients. 3. Presence of toxic megacolon, massive gastrointestinal bleeding, perforation, sepsis, or intra-abdominal abscess. 4. History of ileostomy, proctocolectomy, or subtotal colectomy with ileorectal anastomosis. 5. Presence of high-grade colorectal dysplasia or colorectal cancer. 6. Allergy to mesalazine. 7. Previous use of biologics or small-molecule agents. 8. Ulcerative proctitis (Montreal classification E1).

Design outcomes

Primary

MeasureTime frame
Endoscopic remission (MES=0);—

Secondary

MeasureTime frame
Diagnostic performance of mucosal healing/response based on fecal calprotectin (FC) strategy;Diagnostic performance of mucosal healing/response based on fecal calprotectin (FC) + intestinal ultrasound (IUS) strategy;Mucosal healing criteria (FC =30% from baseline and IUS bowel wall thickness reduction >=2 mm, etc.);Misclassification rate in disease assessment;Patient-reported outcomes (PRO);—

Countries

China

Contacts

Public ContactYang Hong

Peking Union Medical College Hospital

yangh@pumch.cn+86 186 1011 0325

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026