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

Xijing Hospital of Digestive Diseases

Status: Completed

Conditions: Ul

Treatments: Diagnostic Test: Liver Function Test at 12-week; Diagnostic Test: C-reactive Protein Test at 4-week; Diagnostic Test: Erythrocyte Sedimentation Rate Test at 8-week; Diagnostic Test: Kidney Function Test at 4-week; Diagnostic Test: Blood Routine Test at 8-week; Diagnostic Test: Blood Routine Test at 12-week; Diagnostic Test: C-reactive Protein Test at 12-week; Diagnostic Test: Erythrocyte Sedimentation Rate Test at 12-week; Diagnostic Test: Kidney Function Test at 8-week; Diagnostic Test: Kidney Function Test at 12-week; Procedure: Colon Endoscopy Procedure; Drug: 5-ASA (5-Aminosalicylate); Diagnostic Test: Stool Routine Test at 8-week; Diagnostic Test: Erythrocyte Sedimentation Rate Test at 4-week; Diagnostic Test: Liver Function Test at 8-week; Diagnostic Test: Stool Routine Test at 4-week; Diagnostic Test: C-reactive Protein Test at 8-week; Diagnostic Test: Liver Function Test at 4-week; Diagnostic Test: Blood Routine Test at 4-week; Diagnostic Test: Stool Routine Test at 12-week

Study type: Observational

Funder types: Other

Identifiers

NCT06998693

KY20232344-F-1

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

180 participants in 3 patient groups

4-week Evaluation of Disease Progression

Description:

UC patients with initial onset or recurrence whose assessment time interval is set at 4 weeks

Treatment:

Diagnostic Test: Blood Routine Test at 4-week

Diagnostic Test: Liver Function Test at 4-week

Diagnostic Test: Stool Routine Test at 4-week

Diagnostic Test: Erythrocyte Sedimentation Rate Test at 4-week

Drug: 5-ASA (5-Aminosalicylate)

Procedure: Colon Endoscopy Procedure

Diagnostic Test: Kidney Function Test at 4-week

Diagnostic Test: C-reactive Protein Test at 4-week

8-week Evaluation of Disease Progression

Description:

UC patients with initial onset or recurrence whose assessment time interval is set at 8 weeks

Treatment:

Diagnostic Test: C-reactive Protein Test at 8-week

Diagnostic Test: Liver Function Test at 8-week

Diagnostic Test: Stool Routine Test at 8-week

Drug: 5-ASA (5-Aminosalicylate)

Procedure: Colon Endoscopy Procedure

Diagnostic Test: Kidney Function Test at 8-week

Diagnostic Test: Blood Routine Test at 8-week

Diagnostic Test: Erythrocyte Sedimentation Rate Test at 8-week

12-week Evaluation of Disease Progression

Description:

UC patients with initial onset or recurrence whose assessment time interval is set at 12 weeks

Treatment:

Diagnostic Test: Stool Routine Test at 12-week

Drug: 5-ASA (5-Aminosalicylate)

Procedure: Colon Endoscopy Procedure

Diagnostic Test: Kidney Function Test at 12-week

Diagnostic Test: Erythrocyte Sedimentation Rate Test at 12-week

Diagnostic Test: C-reactive Protein Test at 12-week

Diagnostic Test: Blood Routine Test at 12-week

Diagnostic Test: Liver Function Test at 12-week