Status:
NOT_YET_RECRUITING
Efficacy and Safety of Discontinuing 5-ASA in Patients With Inflammatory Bowel Disease
Lead Sponsor:
Pusan National University Hospital
Conditions:
Ulcerative Colitis (UC)
Crohn's Disease
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
This study aims to evaluate the long-term outcomes of discontinuing 5-ASA in UC and CD patients receiving stable biologic or immunomodulator therapy using a prospective cohort based in the Busan-Ulsan...
Detailed Description
In inflammatory bowel disease (IBD), 5-aminosalicylic acid (5-ASA) is widely used as a first-line treatment for ulcerative colitis (UC) and is still prescribed for Crohn's disease (CD). However, for p...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Diagnosis
- o Patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) based on standard diagnostic criteria, including clinical, endoscopic, and histologic findings.
- Treatment Status
- Patients who have been continuously treated with biologic agents (e.g., anti-TNF agents, integrin inhibitors, JAK inhibitors) or immunomodulators (e.g., azathioprine, methotrexate) for at least three months.
- Patients who have been on a stable dose of 5-ASA (mesalamine) for at least three months before study enrollment.
- Disease Activity
- o Patients in clinical remission for at least three months, as defined by the Mayo score for UC or the Crohn's Disease Activity Index (CDAI) for CD.
- Age
- o Adults aged 19 years or older.
- Informed Consent
- o Patients capable of providing written informed consent for study participation.
- Compliance with Study Protocol
- o Patients who can adhere to the study protocol and visit schedule.
- General Health Condition
- o Patients without severe medical conditions that could impact the study or patient safety, such as significant cardiac, renal, or hepatic diseases.
- No recent medication changes
- Patients who have not had any new prescriptions or dose adjustments of corticosteroids, antibiotics, or other medications that could affect IBD within a specified period (e.g., four weeks) before enrollment.
- Exclusion Criteria
- Patients with severe active UC or CD at the time of study enrollment.
- Patients who have been recently hospitalized for IBD-related reasons or undergone IBD-related surgery within three months before enrollment.
- Patients who have had dose modifications of biologics, immunomodulators, or corticosteroids for IBD within three months before enrollment.
- Patients receiving concomitant therapy with other medications that may affect disease activity (e.g., additional anti-inflammatory agents, IBD-related antibiotics).
- Patients with severe cardiac, renal, or hepatic disease or other medical conditions that could interfere with the study.
- Pregnant or breastfeeding women.
- Patients with known allergies or intolerance to 5-ASA or related medications.
- Patients currently participating in another clinical study that may interfere with this study.
- Patients unable to provide informed consent or unlikely to comply with the study protocol and visit schedule.
- Patients with a history of non-response or intolerance to their current biologic or immunomodulator therapy.
- Patients with a history of severe psychiatric disorders that may affect their ability to participate in the study.
Exclusion
Key Trial Info
Start Date :
June 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06878495
Start Date
June 15 2025
End Date
December 31 2025
Last Update
May 29 2025
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