Status:
UNKNOWN
Efficacy of Probiotics for NSAID-induced Enteropathy in Arthritis Patients
Lead Sponsor:
Jae Myung Park
Collaborating Sponsors:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Osteoarthritis
Eligibility:
All Genders
19-75 years
Phase:
PHASE2
Brief Summary
This study aimed to investigate the efficacy of probiotics as a preventive agent for NSAID-induced enteropathy. Arthritis patients are randomly divided into probiotic and placebo groups, and the drug ...
Detailed Description
Background: Due to aging, there are many long-term users of NSAIDs, increasing enteropathy. The prophylactic effect of misoprostol, which is currently used, has not been proven, and misoprostol's lon...
Eligibility Criteria
Inclusion
- Patients with axial SpA who meet the 2009 ASAS criteria or osteoarthritis diagnosed by hand or foot x-rays
Exclusion
- History of taking NSAIDs or antibiotics within the last month
- Those who have been taking probiotics, steroids, or immunosuppressants for a long time
- Abdominal surgical history (exception: appendectomy, cholecystectomy)
- History of gastrointestinal malignant disease
- Abnormal findings requiring drug treatment or surgery in upper gastrointestinal endoscopy (e.g., digestive cancer, acute peptic ulcer, etc.)
- Hemorrhagic disease
- Anemia with hemoglobin less than 10 g/dL
- Past NSAIDs drug side effects (allergy)
Key Trial Info
Start Date :
August 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05993247
Start Date
August 20 2023
End Date
August 31 2025
Last Update
August 15 2023
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