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Efficacy and Safety of Guselkumab in the Treatment of Inflammatory Bowel Disease

Efficacy and Safety of Guselkumab in the Treatment of Inflammatory Bowel Disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113599
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Inflammatory bowel disease

Interventions

Guselkumab-treating Crohn's disease group:None
Guselkumab-treating ulcerative colitis group:None
Healthy control group:None

Sponsors

The Sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Eligible participants were adults aged 18-60 who had voluntarily provided informed consent, with a diagnosis of CD or UC confirmed per the "Consensus on the Diagnosis and Management of Inflammatory Bowel Disease (2018, Beijing)," and were currently on guselkumab therapy. The selection criteria for the healthy volunteer group are voluntary signing of informed consent forms, adults aged 18-60, and healthy volunteers.

Exclusion criteria

Exclusion criteria: Exclusion criteria include subjects who meet any of the following conditions: unwillingness or inability to provide screening biopsies, blood, or stool samples; pregnancy; known bleeding disorder; diagnosis of IBD unclassified (IBD-U); presence of malignancy; acute gastrointestinal infection; diagnosis of colitis of unknown etiology; or diagnosis of an autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus).

Design outcomes

Primary

MeasureTime frame
Clinical response rate;Clinical remission rate;

Secondary

MeasureTime frame
Endoscopic response rate;Endoscopic remission rate;

Countries

China

Contacts

Public ContactHongsheng Yang

The Sixth Affiliated Hospital, Sun Yat-sen University

yhongsheng@mail.sysu.edu.cn+86 20 3866 3423

Outcome results

None listed

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