Efficacy of Probiotics for NSAID-induced Enteropathy in Arthritis Patients — NSAID  

Osteoarthritis Clinical Trial

Official title: Efficacy of Probiotics for Non-steroidal Anti-inflammatory Drug-induced Enteropathy in Arthritis Patients: A Double-blinded Pilot Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial 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 is administered for eight weeks. Before and after drug administration, the patient's symptoms/degree of small bowel injuries on capsule endoscopy/microbiome composition and diversity were investigated.

Clinical Trial 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 long-term compliance and safety remain questionable. Rebamipide shows insignificant effects in both treatment and prophylaxis.

Probiotics have been reported to affect enteropathy in animal and human studies. However, there needs to be more verification studies, and there needs to be confirmatory studies on the importance of the microbiome in the small bowel. However, it is expected that there will be fewer complications and less patient resistance, resulting in higher drug compliance.

Purpose: To identify the efficacy of probiotics on NSAID-induced enteropathy in arthritis patients by capsule endoscopy and questionnaire, and to analysis the composition and diversity of the microbiome

Design: Double-blinded randomized controlled, pilot study

Participant: Patients diagnosed with osteoarthritis and starting NSAIDs

Methods: Randomly administering Probiotics or Placebo for eight weeks and comparing "before and after administration" in arthritis patients

1. Survey of patient symptoms for enteropathy

2. Recovery of small bowel mucosal injuries in capsule endoscopy

3. Analysis of the composition and diversity of the microbiome

4. Adverse events

Outcome

• Primary outcome: To assess whether probiotics can reduce small bowel injuries caused by NSAIDs

• Secondary outcome:

1. To investigate whether probiotics can reduce gastrointestinal symptoms caused by NSAIDs

2. To identify the improvement of arthritis symptoms

3. To examine whether the distribution of the microbiome can be converted into beneficial bacteria by administering probiotics ;

Related Conditions & MeSH terms

• Arthritis
• Intestinal Diseases
• Osteoarthritis

• NCT number: NCT05993247
• Study type: Interventional
• Source: Seoul St. Mary's Hospital
• Contact: Jae Myung Park, MD
• Phone: +82222586023
• Email: parkjerry@catholic.ac.kr
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 20, 2023
• Completion date: August 31, 2025