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
NCT ID: NCT06998693
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
180 participants
OBSERVATIONAL
2024-08-01
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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4-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 4 weeks
5-ASA (5-Aminosalicylate)
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).
Colon Endoscopy Procedure
Participants in all groups will receive a standard Colon Endoscopy Procedure at 48-week.
Blood Routine Test at 4-week
Participants in will receive a standard Blood Routine Test at 4-week.
Stool Routine Test at 4-week
Participants in will receive a standard Stool Routine Test at 4-week.
Erythrocyte Sedimentation Rate Test at 4-week
Participants in will receive a standard Erythrocyte Sedimentation Rate Test at 4-week.
C-reactive Protein Test at 4-week
Participants in will receive a standard C-reactive Protein Test at 4-week.
Liver Function Test at 4-week
Participants in will receive a standard Liver Function Test at 4-week.
Kidney Function Test at 4-week
Participants in will receive a standard 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
5-ASA (5-Aminosalicylate)
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).
Colon Endoscopy Procedure
Participants in all groups will receive a standard Colon Endoscopy Procedure at 48-week.
Blood Routine Test at 8-week
Participants in will receive a standard Blood Routine Test at 8-week.
Stool Routine Test at 8-week
Participants in will receive a standard Stool Routine Test at 8-week.
Erythrocyte Sedimentation Rate Test at 8-week
Participants in will receive a standard Erythrocyte Sedimentation Rate Test at 8-week.
C-reactive Protein Test at 8-week
Participants in will receive a standard C-reactive Protein Test at 8-week.
Liver Function Test at 8-week
Participants in will receive a standard Liver Function Test at 8-week.
Kidney Function Test at 8-week
Participants in will receive a standard 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
5-ASA (5-Aminosalicylate)
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).
Colon Endoscopy Procedure
Participants in all groups will receive a standard Colon Endoscopy Procedure at 48-week.
Blood Routine Test at 12-week
Participants in will receive a standard Blood Routine Test at 12-week.
Stool Routine Test at 12-week
Participants in will receive a standard Stool Routine Test at 12-week.
Erythrocyte Sedimentation Rate Test at 12-week
Participants in will receive a standard Erythrocyte Sedimentation Rate Test at 12-week.
C-reactive Protein Test at 12-week
Participants in will receive a standard C-reactive Protein Test at 12-week.
Liver Function Test at 12-week
Participants in will receive a standard Liver Function Test at 12-week.
Kidney Function Test at 12-week
Participants in will receive a standard Kidney Function Test at 12-week.
Interventions
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5-ASA (5-Aminosalicylate)
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).
Colon Endoscopy Procedure
Participants in all groups will receive a standard Colon Endoscopy Procedure at 48-week.
Blood Routine Test at 4-week
Participants in will receive a standard Blood Routine Test at 4-week.
Blood Routine Test at 8-week
Participants in will receive a standard Blood Routine Test at 8-week.
Blood Routine Test at 12-week
Participants in will receive a standard Blood Routine Test at 12-week.
Stool Routine Test at 4-week
Participants in will receive a standard Stool Routine Test at 4-week.
Stool Routine Test at 8-week
Participants in will receive a standard Stool Routine Test at 8-week.
Stool Routine Test at 12-week
Participants in will receive a standard Stool Routine Test at 12-week.
Erythrocyte Sedimentation Rate Test at 4-week
Participants in will receive a standard Erythrocyte Sedimentation Rate Test at 4-week.
Erythrocyte Sedimentation Rate Test at 8-week
Participants in will receive a standard Erythrocyte Sedimentation Rate Test at 8-week.
Erythrocyte Sedimentation Rate Test at 12-week
Participants in will receive a standard Erythrocyte Sedimentation Rate Test at 12-week.
C-reactive Protein Test at 4-week
Participants in will receive a standard C-reactive Protein Test at 4-week.
C-reactive Protein Test at 8-week
Participants in will receive a standard C-reactive Protein Test at 8-week.
C-reactive Protein Test at 12-week
Participants in will receive a standard C-reactive Protein Test at 12-week.
Liver Function Test at 4-week
Participants in will receive a standard Liver Function Test at 4-week.
Liver Function Test at 8-week
Participants in will receive a standard Liver Function Test at 8-week.
Liver Function Test at 12-week
Participants in will receive a standard Liver Function Test at 12-week.
Kidney Function Test at 4-week
Participants in will receive a standard Kidney Function Test at 4-week.
Kidney Function Test at 8-week
Participants in will receive a standard Kidney Function Test at 8-week.
Kidney Function Test at 12-week
Participants in will receive a standard Kidney Function Test at 12-week.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
59 Years
ALL
No
Sponsors
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Xijing Hospital of Digestive Diseases
OTHER
Responsible Party
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Jie Liang
Professor
Locations
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Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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KY20232344-F-1
Identifier Type: -
Identifier Source: org_study_id
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