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

Launched by XIJING HOSPITAL OF DIGESTIVE DISEASES · May 29, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how the timing of symptom assessments affects the effectiveness of a medication called 5-ASA for patients with mild to moderate ulcerative colitis (UC). Ulcerative colitis is a condition that causes inflammation in the intestines, leading to symptoms like stomach pain and diarrhea. The study will track patients' symptoms and test results at different points during their treatment (specifically at 4, 8, and 12 weeks) to see how quickly the medication works and to identify which patients respond well or poorly to the treatment. This information may help doctors tailor treatments to individual patients in the future.

To be eligible for this study, participants should be adults aged 18 to 59 who have recently been diagnosed with ulcerative colitis or have had mild to moderate UC that has returned after a period of improvement. They should also be willing to follow the study guidelines and provide written consent. Participants will receive either oral mesalazine or a combination of oral and topical mesalazine as part of their treatment plan. This study is not yet recruiting, but if you're interested, it's a chance to contribute to important research that may improve treatment for others with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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);
• • 2. Age: 18-59 years old;
• • 3. The attending physician will propose an oral mesalazine or an oral w/ topical mesalazine combined treatment plan based on the patient's condition;
• • 4. 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:
• • 1. Use any form of hormone within the past 14 days;
• • 2. Have received immunosuppressive therapy within the past 90 days;
• • 3. Have used infliximab, adalimumab, or vedolizumab within the past 60 days;
• • 4. Have taken anti-diarrheal drugs within the past 3 days;
• • 5. Have participated in any clinical trial within the past 3 months;
• • 6. Allergic to mesalazine or salicylic acid preparations (except sulfasalazine), including severe adverse reactions, liver and kidney diseases, heart and lung diseases, malignant tumors, etc.;
• • 7. Have had severe liver and kidney diseases, heart and lung diseases, hematological diseases and pancreatic diseases in the past;
• • 8. Pregnant or lactating women;
• • 9. Patients who have withdrawn their informed consent.