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

NCT06998693 | Completed

• 1 other identifier: KY20232344-F-1
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Ul

Keywords

Ulcerative colitis; 5-aminosalicylic acid; Symptom Assessment Timing; Observational Study

Outcome Measures

Primary Outcomes (1)

• The Endoscopic Remission Rate

  The primary outcome measure is the endoscopic remission rate at 48 weeks from enrollment, defined as the proportion of patients achieving a Mayo endoscopic subscore of 0 or 1. Participants are adults (18-59 years) with newly diagnosed or relapsing mild-to-moderate ulcerative colitis (modified Mayo score 3-10) receiving oral or oral-plus-topical mesalazine therapy. Patients with recent use of corticosteroids, immunosuppressants, biologics, or other confounding treatments are excluded. Endoscopic assessment is performed at week 48 to evaluate mucosal healing, and the remission rate is calculated based on the number of patients meeting the endoscopic criteria.

  48 weeks From Enrollment

Secondary Outcomes (4)

• The symptom improvement at 12-week after enrollment

  12-week after enrollment

• The symptom remission at 12-week after enrollment

  12-week after enrollment

• The clinical improvement at 12-week after enrollment

  12-week after enrollment

• The clinical remission at 12-week after enrollment

  12-week after enrollment

Study Arms (3)

4-week Evaluation of Disease Progression

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

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

8-week Evaluation of Disease Progression

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

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

12-week Evaluation of Disease Progression

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

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

Interventions

5-ASA (5-Aminosalicylate) DRUG

Specialist doctors decide the administration method of 5-ASA based on the patient's condition (all groups), mainly including topical therapy, or oral therapy (2-4 gram/day).

12-week Evaluation of Disease Progression; 4-week Evaluation of Disease Progression; 8-week Evaluation of Disease Progression

Colon Endoscopy Procedure PROCEDURE

Participants in all groups will receive a standard Colon Endoscopy Procedure at 48-week.

12-week Evaluation of Disease Progression; 4-week Evaluation of Disease Progression; 8-week Evaluation of Disease Progression

Blood Routine Test at 4-week DIAGNOSTIC_TEST

Participants in will receive a standard Blood Routine Test at 4-week.

4-week Evaluation of Disease Progression

Blood Routine Test at 8-week DIAGNOSTIC_TEST

Participants in will receive a standard Blood Routine Test at 8-week.

8-week Evaluation of Disease Progression

Blood Routine Test at 12-week DIAGNOSTIC_TEST

Participants in will receive a standard Blood Routine Test at 12-week.

12-week Evaluation of Disease Progression

Stool Routine Test at 4-week DIAGNOSTIC_TEST

Participants in will receive a standard Stool Routine Test at 4-week.

4-week Evaluation of Disease Progression

Stool Routine Test at 8-week DIAGNOSTIC_TEST

Participants in will receive a standard Stool Routine Test at 8-week.

8-week Evaluation of Disease Progression

Stool Routine Test at 12-week DIAGNOSTIC_TEST

Participants in will receive a standard Stool Routine Test at 12-week.

12-week Evaluation of Disease Progression

Erythrocyte Sedimentation Rate Test at 4-week DIAGNOSTIC_TEST

Participants in will receive a standard Erythrocyte Sedimentation Rate Test at 4-week.

4-week Evaluation of Disease Progression

Erythrocyte Sedimentation Rate Test at 8-week DIAGNOSTIC_TEST

Participants in will receive a standard Erythrocyte Sedimentation Rate Test at 8-week.

8-week Evaluation of Disease Progression

Erythrocyte Sedimentation Rate Test at 12-week DIAGNOSTIC_TEST

Participants in will receive a standard Erythrocyte Sedimentation Rate Test at 12-week.

12-week Evaluation of Disease Progression

C-reactive Protein Test at 4-week DIAGNOSTIC_TEST

Participants in will receive a standard C-reactive Protein Test at 4-week.

4-week Evaluation of Disease Progression

C-reactive Protein Test at 8-week DIAGNOSTIC_TEST

Participants in will receive a standard C-reactive Protein Test at 8-week.

8-week Evaluation of Disease Progression

C-reactive Protein Test at 12-week DIAGNOSTIC_TEST

Participants in will receive a standard C-reactive Protein Test at 12-week.

12-week Evaluation of Disease Progression

Liver Function Test at 4-week DIAGNOSTIC_TEST

Participants in will receive a standard Liver Function Test at 4-week.

4-week Evaluation of Disease Progression

Liver Function Test at 8-week DIAGNOSTIC_TEST

Participants in will receive a standard Liver Function Test at 8-week.

8-week Evaluation of Disease Progression

Liver Function Test at 12-week DIAGNOSTIC_TEST

Participants in will receive a standard Liver Function Test at 12-week.

12-week Evaluation of Disease Progression

Kidney Function Test at 4-week DIAGNOSTIC_TEST

Participants in will receive a standard Kidney Function Test at 4-week.

4-week Evaluation of Disease Progression

Kidney Function Test at 8-week DIAGNOSTIC_TEST

Participants in will receive a standard Kidney Function Test at 8-week.

8-week Evaluation of Disease Progression

Kidney Function Test at 12-week DIAGNOSTIC_TEST

Participants in will receive a standard Kidney Function Test at 12-week.

12-week Evaluation of Disease Progression

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This study aims to compare the impact of the time point of the first assessment of patients (4th, 8th, and 12th weeks) on the short-term efficacy of 5-ASA on ulcerative colitis. The patients are divided into three groups: the 4-week assessment group, the 8-week assessment group, and the 12-week assessment group, with 60 patients in each group, totaling 180 patients.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Related Publications (7)

• Bressler B, Marshall JK, Bernstein CN, Bitton A, Jones J, Leontiadis GI, Panaccione R, Steinhart AH, Tse F, Feagan B; Toronto Ulcerative Colitis Consensus Group. Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis: the Toronto consensus. Gastroenterology. 2015 May;148(5):1035-1058.e3. doi: 10.1053/j.gastro.2015.03.001. Epub 2015 Mar 4.

  PMID: 25747596 BACKGROUND

• Orchard TR, van der Geest SA, Travis SP. Randomised clinical trial: early assessment after 2 weeks of high-dose mesalazine for moderately active ulcerative colitis - new light on a familiar question. Aliment Pharmacol Ther. 2011 May;33(9):1028-35. doi: 10.1111/j.1365-2036.2011.04620.x. Epub 2011 Mar 8.

  PMID: 21385195 BACKGROUND

• Hanauer SB, Sandborn WJ, Kornbluth A, Katz S, Safdi M, Woogen S, Regalli G, Yeh C, Smith-Hall N, Ajayi F. Delayed-release oral mesalamine at 4.8 g/day (800 mg tablet) for the treatment of moderately active ulcerative colitis: the ASCEND II trial. Am J Gastroenterol. 2005 Nov;100(11):2478-85. doi: 10.1111/j.1572-0241.2005.00248.x.

  PMID: 16279903 BACKGROUND

• Pruitt R, Hanson J, Safdi M, Wruble L, Hardi R, Johanson J, Koval G, Riff D, Winston B, Cross A, Doty P, Johnson LK. Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute mild-to-moderate ulcerative colitis. Am J Gastroenterol. 2002 Dec;97(12):3078-86. doi: 10.1111/j.1572-0241.2002.07103.x.

  PMID: 12492193 BACKGROUND

• Levine DS, Riff DS, Pruitt R, Wruble L, Koval G, Sales D, Bell JK, Johnson LK. A randomized, double blind, dose-response comparison of balsalazide (6.75 g), balsalazide (2.25 g), and mesalamine (2.4 g) in the treatment of active, mild-to-moderate ulcerative colitis. Am J Gastroenterol. 2002 Jun;97(6):1398-407. doi: 10.1111/j.1572-0241.2002.05781.x.

  PMID: 12094857 BACKGROUND

• Xu L, He B, Sun Y, Li J, Shen P, Hu L, Liu G, Wang J, Duan L, Zhan S, Wang S. Incidence of Inflammatory Bowel Disease in Urban China: A Nationwide Population-based Study. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3379-3386.e29. doi: 10.1016/j.cgh.2023.08.013. Epub 2023 Sep 1.

  PMID: 37660767 BACKGROUND

• Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007 May 12;369(9573):1627-40. doi: 10.1016/S0140-6736(07)60750-8.

  PMID: 17499605 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 31, 2025
• Study Start: August 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

CN (1)