NCT06998693Completed
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
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 180 (actual)
- First submitted
- 6 May 2025
- Start date
- Aug 2024
- Primary completion date
- Aug 2025
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Diseases
- Ulcerative colitis
- NCT number
- NCT06998693
What you commit to
- Study type: Observational
- Participants enrolled: 180
- From Aug 2024 to the primary completion date, Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received immunosuppressive therapy within the past 90 days;
- Have taken anti-diarrheal drugs within the past 3 days;
Other illness
- 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;
Other
- Use any form of hormone within the past 14 days;
- Have used infliximab, adalimumab, or vedolizumab within the past 60 days;
- Have participated in any clinical trial within the past 3 months;
- Pregnant or lactating women;
- Patients who have withdrawn their informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 59 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xijing Hospital of Digestive Diseases Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.