A Single-Center Observational Study on the Impact of Symptom Assessment Timing on the Short-Term … (NCT06998693) | Clinical Trial Compass
CompletedNot Applicable
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
China180 participantsStarted 2024-08-01
Plain-language 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.
Who can participate
Age range18 Years – 59 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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;