NCT05993247

Efficacy of Probiotics for NSAID-induced Enteropathy in Arthritis Patients

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Jae Myung Park · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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 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

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Probiotics capsule	Subjects will take a probiotics combination capsule (Bacillus Subtilis 150 mg /Clostridium Burtyricum Toa 150 mg /Saccharomyces Boulardii 113 mg) three times a day for 8 weeks in combination with NSAIDs
COMBINATION_PRODUCT	Placebo capsule	Subjects will take a placebo capsule identical in shape and size to probiotics capsule three times a day for 8 weeks in combination with NSAIDs

Timeline

• Start date: 2023-08-20
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2023-08-15
• Last updated: 2023-08-15