Status:
COMPLETED
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
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Conditions:
Ul
Eligibility:
All Genders
18-59 years
Brief 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 co...
Eligibility Criteria
Inclusion
- According to the diagnostic criteria of the China's 2023 Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Disease, the disease status is newly diagnosed ulcerative colitis (UC) or mild to moderate active UC with remission followed by recurrence (modified Mayo score 3-10 points);
- Age: 18-59 years old;
- The attending physician will propose an oral mesalazine or an oral w/ topical mesalazine combined treatment plan based on the patient's condition;
- Patients who are abble to and are willing to comply with the research protocol can provide a signed and dated written informed consent form.
Exclusion
- Use any form of hormone within the past 14 days;
- Have received immunosuppressive therapy within the past 90 days;
- Have used infliximab, adalimumab, or vedolizumab within the past 60 days;
- Have taken anti-diarrheal drugs within the past 3 days;
- Have participated in any clinical trial within the past 3 months;
- Allergic to mesalazine or salicylic acid preparations (except sulfasalazine), including severe adverse reactions, liver and kidney diseases, heart and lung diseases, malignant tumors, etc.;
- Have had severe liver and kidney diseases, heart and lung diseases, hematological diseases and pancreatic diseases in the past;
- Pregnant or lactating women;
- Patients who have withdrawn their informed consent.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06998693
Start Date
August 1 2024
End Date
September 30 2025
Last Update
November 25 2025
Active Locations (1)
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1
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032