Clinical trial NCT06998693: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ul
Keywords: Ulcerative colitis
5-aminosalicylic acid
Symptom Assessment Timing
Observational Study
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: The Endoscopic Remission Rate
timeFrame: 48 weeks From Enrollment
Secondary outcomes:
measure: The symptom improvement at 12-week after enrollment
timeFrame: 12-week after enrollment
measure: The symptom remission at 12-week after enrollment
timeFrame: 12-week after enrollment
measure: The clinical improvement at 12-week after enrollment
timeFrame: 12-week after enrollment
measure: The clinical remission at 12-week after enrollment
timeFrame: 12-week after enrollment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.