UlNCT06998693
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
An observational study of Ul, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Ul
- What is being tested?
- 5-ASA (5-Aminosalicylate), Colon Endoscopy Procedure and Blood Routine Test at 4-week
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- 5-ASA (5-Aminosalicylate), Colon Endoscopy Procedure, Blood Routine Test at 4-week, Blood Routine Test at 8-week, Blood Routine Test at 12-week
- Keywords
- Ulcerative colitis, 5-aminosalicylic acid, Symptom Assessment Timing, Observational Study
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Colon Endoscopy ProcedureProcedure or surgery
Participants in all groups will receive a standard Colon Endoscopy Procedure at 48-week.
Blood Routine Test at 4-weekDiagnostic test
Participants in will receive a standard Blood Routine Test at 4-week.
Blood Routine Test at 8-weekDiagnostic test
Participants in will receive a standard Blood Routine Test at 8-week.
Blood Routine Test at 12-weekDiagnostic test
Participants in will receive a standard Blood Routine Test at 12-week.
Stool Routine Test at 4-weekDiagnostic test
Participants in will receive a standard Stool Routine Test at 4-week.
Stool Routine Test at 8-weekDiagnostic test
Participants in will receive a standard Stool Routine Test at 8-week.
Stool Routine Test at 12-weekDiagnostic test
Participants in will receive a standard Stool Routine Test at 12-week.
Erythrocyte Sedimentation Rate Test at 4-weekDiagnostic test
Participants in will receive a standard Erythrocyte Sedimentation Rate Test at 4-week.
Erythrocyte Sedimentation Rate Test at 8-weekDiagnostic test
Participants in will receive a standard Erythrocyte Sedimentation Rate Test at 8-week.
Erythrocyte Sedimentation Rate Test at 12-weekDiagnostic test
Participants in will receive a standard Erythrocyte Sedimentation Rate Test at 12-week.
C-reactive Protein Test at 4-weekDiagnostic test
Participants in will receive a standard C-reactive Protein Test at 4-week.
C-reactive Protein Test at 8-weekDiagnostic test
Participants in will receive a standard C-reactive Protein Test at 8-week.
C-reactive Protein Test at 12-weekDiagnostic test
Participants in will receive a standard C-reactive Protein Test at 12-week.
Liver Function Test at 4-weekDiagnostic test
Participants in will receive a standard Liver Function Test at 4-week.
Liver Function Test at 8-weekDiagnostic test
Participants in will receive a standard Liver Function Test at 8-week.
Liver Function Test at 12-weekDiagnostic test
Participants in will receive a standard Liver Function Test at 12-week.
Kidney Function Test at 4-weekDiagnostic test
Participants in will receive a standard Kidney Function Test at 4-week.
Kidney Function Test at 8-weekDiagnostic test
Participants in will receive a standard Kidney Function Test at 8-week.
Kidney Function Test at 12-weekDiagnostic test
Participants in will receive a standard Kidney Function Test at 12-week.
| Study group | Role | What they receive |
|---|---|---|
| 4-week Evaluation of Disease Progression | UC patients with initial onset or recurrence whose assessment time interval is set at 4 weeks Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks From Enrollment
Secondary outcomes (4)
The symptom improvement at 12-week after enrollment
This outcome measure is symptom improvement at 12 weeks after enrollment, assessed by the change in modified Mayo score from baseline. This score evaluates key ulcerative colitis symptoms, including stool frequency, rectal bleeding, and urgency, with higher scores indicating greater severity. Participants are adults with newly diagnosed or relapsing mild-to-moderate UC receiving mesalazine therapy. Symptom severity is recorded at baseline and at week 12, and improvement is defined as a reduction in the total modified Mayo score, reflecting clinical response to treatment during the 12-week period.
Measured: 12-week after enrollment
The symptom remission at 12-week after enrollment
This outcome measures the symptom remission at 12 weeks post-enrollment in the study population of adult UC patients treated with mesalazine therapy. Eligible participants are those meeting the 2023 Chinese Consensus diagnostic criteria for newly diagnosed or mild-to-moderate active ulcerative colitis (baseline modified Mayo score 3-10), with no recent use of corticosteroids, immunosuppressants, biologics, or anti-diarrheal medications, and without serious comorbidities, concurrent trial participation, or pregnancy. Symptom remission is defined as normal stool frequency and no rectal bleeding or urgency, at the 12-week follow-up visit. This stringent definition indicates minimal disease activity across all symptom domains and is used to evaluate the efficacy of mesalazine in inducing clinical remission by the 12-week mark.
Measured: 12-week after enrollment
The clinical improvement at 12-week after enrollment
This outcome measures the proportion of patients achieving clinical improvement at the 12-week follow-up after enrollment. Clinical improvement is defined as a marked reduction in ulcerative colitis disease activity from baseline. Specifically, a patient must exhibit a decrease in the total modified Mayo score by at least 3 points and at least 30% relative to their baseline score, indicating a significant overall improvement in symptoms. In addition, there must be an improvement in rectal bleeding, evidenced by a decrease of at least 1 point in the rectal bleeding subscore. All participants will be assessed at week 12 post-enrollment to determine if they meet these criteria, reflecting meaningful clinical improvement after 12 weeks of mesalazine therapy.
Measured: 12-week after enrollment
The clinical remission at 12-week after enrollment
Clinical remission at 12 weeks after enrollment is a key secondary outcome measure, defined as achieving a total modified Mayo score of ≤2 with no individual subscore greater than 1 at the 12-week follow-up. This outcome evaluates the effectiveness of 12-week mesalazine therapy (oral or oral-plus-topical) in inducing remission in adult ulcerative colitis patients. Participants are aged 18-59 years and meet the 2023 Chinese Consensus diagnostic criteria for newly diagnosed or mild-to-moderate active UC, with a baseline modified Mayo score between 3 and 10. Patients with recent use of corticosteroids, immunosuppressants, biologic therapies, or anti-diarrheal medications, as well as those in other clinical trials or with serious comorbidities or pregnancy, are excluded. The proportion of patients meeting the clinical remission criteria at week 12 will be determined, providing a clear measure of therapeutic success in this population.
Measured: 12-week after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Aug 2024
- Primary completion31 Aug 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for UlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Liang, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998693
- Sponsor's protocol ID
- KY20232344-F-1
- Status last verified
- Nov 2025
- First submitted
- 6 May 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25747596Orchard 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.
PubMed 21385195Hanauer 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.
PubMed 16279903Pruitt 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.
PubMed 12492193Levine 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.
PubMed 12094857Xu 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.
PubMed 37660767Baumgart 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.
PubMed 17499605
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06998693
- Acronym / sponsor ID
- KY20232344-F-1
- Conditions
- Ul
- Keywords
- Ulcerative colitis, 5-aminosalicylic acid, Symptom Assessment Timing, Observational Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4-week Evaluation of Disease Progression | – | 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-weekUC patients with initial onset or recurrence whose assessment time interval is set at 4 weeks |
| 8-week Evaluation of Disease Progression | – | 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-weekUC patients with initial onset or recurrence whose assessment time interval is set at 8 weeks |
| 12-week Evaluation of Disease Progression | – | 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-weekUC patients with initial onset or recurrence whose assessment time interval is set at 12 weeks |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | 12-week Evaluation of Disease Progression, 4-week Evaluation of Disease Progression, 8-week Evaluation of Disease Progression |
| Colon Endoscopy ProcedureParticipants in all groups will receive a standard Colon Endoscopy Procedure at 48-week. | Procedure or surgery | 12-week Evaluation of Disease Progression, 4-week Evaluation of Disease Progression, 8-week Evaluation of Disease Progression |
| Blood Routine Test at 4-weekParticipants in will receive a standard Blood Routine Test at 4-week. | Diagnostic test | 4-week Evaluation of Disease Progression |
| Blood Routine Test at 8-weekParticipants in will receive a standard Blood Routine Test at 8-week. | Diagnostic test | 8-week Evaluation of Disease Progression |
| Blood Routine Test at 12-weekParticipants in will receive a standard Blood Routine Test at 12-week. | Diagnostic test | 12-week Evaluation of Disease Progression |
| Stool Routine Test at 4-weekParticipants in will receive a standard Stool Routine Test at 4-week. | Diagnostic test | 4-week Evaluation of Disease Progression |
| Stool Routine Test at 8-weekParticipants in will receive a standard Stool Routine Test at 8-week. | Diagnostic test | 8-week Evaluation of Disease Progression |
| Stool Routine Test at 12-weekParticipants in will receive a standard Stool Routine Test at 12-week. | Diagnostic test | 12-week Evaluation of Disease Progression |
| Erythrocyte Sedimentation Rate Test at 4-weekParticipants in will receive a standard Erythrocyte Sedimentation Rate Test at 4-week. | Diagnostic test | 4-week Evaluation of Disease Progression |
| Erythrocyte Sedimentation Rate Test at 8-weekParticipants in will receive a standard Erythrocyte Sedimentation Rate Test at 8-week. | Diagnostic test | 8-week Evaluation of Disease Progression |
| Erythrocyte Sedimentation Rate Test at 12-weekParticipants in will receive a standard Erythrocyte Sedimentation Rate Test at 12-week. | Diagnostic test | 12-week Evaluation of Disease Progression |
| C-reactive Protein Test at 4-weekParticipants in will receive a standard C-reactive Protein Test at 4-week. | Diagnostic test | 4-week Evaluation of Disease Progression |
| C-reactive Protein Test at 8-weekParticipants in will receive a standard C-reactive Protein Test at 8-week. | Diagnostic test | 8-week Evaluation of Disease Progression |
| C-reactive Protein Test at 12-weekParticipants in will receive a standard C-reactive Protein Test at 12-week. | Diagnostic test | 12-week Evaluation of Disease Progression |
| Liver Function Test at 4-weekParticipants in will receive a standard Liver Function Test at 4-week. | Diagnostic test | 4-week Evaluation of Disease Progression |
| Liver Function Test at 8-weekParticipants in will receive a standard Liver Function Test at 8-week. | Diagnostic test | 8-week Evaluation of Disease Progression |
| Liver Function Test at 12-weekParticipants in will receive a standard Liver Function Test at 12-week. | Diagnostic test | 12-week Evaluation of Disease Progression |
| Kidney Function Test at 4-weekParticipants in will receive a standard Kidney Function Test at 4-week. | Diagnostic test | 4-week Evaluation of Disease Progression |
| Kidney Function Test at 8-weekParticipants in will receive a standard Kidney Function Test at 8-week. | Diagnostic test | 8-week Evaluation of Disease Progression |
| Kidney Function Test at 12-weekParticipants in will receive a standard Kidney Function Test at 12-week. | Diagnostic test | 12-week Evaluation of Disease Progression |
Primary outcome
The Endoscopic Remission Rate
Time frame: 48 weeks From Enrollment
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.
4 secondary outcomes
The symptom improvement at 12-week after enrollment
Time frame: 12-week after enrollment
The symptom remission at 12-week after enrollment
Time frame: 12-week after enrollment
The clinical improvement at 12-week after enrollment
Time frame: 12-week after enrollment
The clinical remission at 12-week after enrollment
Time frame: 12-week after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 25747596Bressler 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.
- Background: PubMed 21385195Orchard 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.
- Background: PubMed 16279903Hanauer 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.
- Background: PubMed 12492193Pruitt 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.
- Background: PubMed 12094857Levine 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.
- Background: PubMed 37660767Xu 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.
- Background: PubMed 17499605Baumgart 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ul, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Endoscopic Remission Rate (time frame: 48 weeks From Enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06998693, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.