NCT06998693

A Single-Center Observational Study on the Impact of Symptom Assessment Timing on the Short-Term Efficacy of 5-ASA Therapy in Patients With Initial-Onset or Relapsed Mild-to-Moderate Active Ulcerative Colitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 180 (actual)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

This study aims to collect the relevant clinical examination results of patients during the 5-ASA treatment period through opportunistic sampling of patients with mild to moderate active ulcerative colitis (UC). The study compares the impact of the time nodes of the first assessment (4th, 8th, and 12th weeks) on the short-term efficacy of 5-ASA. By integrating the dynamic changes of symptom scores and related biomarkers, the study clarifies the time trajectory of symptom relief in patients with mild to moderate UC, identifies the characteristics of early responders and non-responders, and further explores the association between baseline clinical features and treatment responses, thereby assisting in individualized treatment decisions.

Conditions

• Ul

Interventions

Type	Name	Description
DRUG	5-ASA (5-Aminosalicylate)	Specialist doctors decide the administration method of 5-ASA based on the patient's condition (all groups), mainly including topical therapy, or oral therapy (2-4 gram/day).
PROCEDURE	Colon Endoscopy Procedure	Participants in all groups will receive a standard Colon Endoscopy Procedure at 48-week.
DIAGNOSTIC_TEST	Blood Routine Test at 4-week	Participants in will receive a standard Blood Routine Test at 4-week.
DIAGNOSTIC_TEST	Blood Routine Test at 8-week	Participants in will receive a standard Blood Routine Test at 8-week.
DIAGNOSTIC_TEST	Blood Routine Test at 12-week	Participants in will receive a standard Blood Routine Test at 12-week.
DIAGNOSTIC_TEST	Stool Routine Test at 4-week	Participants in will receive a standard Stool Routine Test at 4-week.
DIAGNOSTIC_TEST	Stool Routine Test at 8-week	Participants in will receive a standard Stool Routine Test at 8-week.
DIAGNOSTIC_TEST	Stool Routine Test at 12-week	Participants in will receive a standard Stool Routine Test at 12-week.
DIAGNOSTIC_TEST	Erythrocyte Sedimentation Rate Test at 4-week	Participants in will receive a standard Erythrocyte Sedimentation Rate Test at 4-week.
DIAGNOSTIC_TEST	Erythrocyte Sedimentation Rate Test at 8-week	Participants in will receive a standard Erythrocyte Sedimentation Rate Test at 8-week.
DIAGNOSTIC_TEST	Erythrocyte Sedimentation Rate Test at 12-week	Participants in will receive a standard Erythrocyte Sedimentation Rate Test at 12-week.
DIAGNOSTIC_TEST	C-reactive Protein Test at 4-week	Participants in will receive a standard C-reactive Protein Test at 4-week.
DIAGNOSTIC_TEST	C-reactive Protein Test at 8-week	Participants in will receive a standard C-reactive Protein Test at 8-week.
DIAGNOSTIC_TEST	C-reactive Protein Test at 12-week	Participants in will receive a standard C-reactive Protein Test at 12-week.
DIAGNOSTIC_TEST	Liver Function Test at 4-week	Participants in will receive a standard Liver Function Test at 4-week.
DIAGNOSTIC_TEST	Liver Function Test at 8-week	Participants in will receive a standard Liver Function Test at 8-week.
DIAGNOSTIC_TEST	Liver Function Test at 12-week	Participants in will receive a standard Liver Function Test at 12-week.
DIAGNOSTIC_TEST	Kidney Function Test at 4-week	Participants in will receive a standard Kidney Function Test at 4-week.
DIAGNOSTIC_TEST	Kidney Function Test at 8-week	Participants in will receive a standard Kidney Function Test at 8-week.
DIAGNOSTIC_TEST	Kidney Function Test at 12-week	Participants in will receive a standard Kidney Function Test at 12-week.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-08-31
• Completion: 2025-09-30
• First posted: 2025-05-31
• Last updated: 2025-11-25

Locations

1 site across 1 country: China