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Transmural healing evaluated by endoscopic ultrasound in patients with moderate to severe active Crohn's disease in China treated with ustekinumab: a prospective single-center study

Transmural healing evaluated by endoscopic ultrasound in patients with moderate to severe active Crohn's disease in China treated with ustekinumab: a prospective single-center study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078772
Enrollment
Unknown
Registered
2023-12-18
Start date
2023-12-20
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Crohn's disease

Interventions

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age= 18 years old; 2) The diagnosis of CD is in line with the 2018 "Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Disease"; 3) Patients with moderate to severe active CD (CDAI=220). 4) Use ustekinumab for induction therapy and/or maintenance therapy.

Exclusion criteria

Exclusion criteria: a) contraindications to ustekinumab; b) diagnosed with ulcerative colitis (UC) or indeterminate colitis (IC) or IBDU; c) any type of bowel resection or other abdominal surgery within the past 3 months, or a history of > 3 previous bowel resections; d) Severe intestinal strictures, toxic megacolon or explosive enteritis, which may require surgery during the visit; e) history of cancer; f) In a state of severe infection (combined clinical, doctor's judgment). g) Baseline bowel wall thickness (BWT) is normal for all bowel segments (terminal ileum= 2.0 mm, colonic = 3.0 mm)

Design outcomes

Primary

MeasureTime frame
C-reactive protein;Fecal calprotectin;Blood routine;Blood biochemistry;ESR;Transmural healing evaluated by endoscopic ultrasound;

Secondary

MeasureTime frame
T-SPOT;

Countries

China

Contacts

Public ContactWei Han

The First Affiliated Hospital of Anhui Medical University

hwbb1016@aliyun.com+86 139 5515 9771

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026