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Efficacy of Probiotics for NSAID-induced Enteropathy in Arthritis Patients

NCT05993247 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-08-15

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    collaborator INDUSTRY

  • Jae Myung Park

    lead OTHER

Principal Investigators

  • Jae Myung Park, MD · The Catholic University of Korea

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-20
Primary Completion
2025-08-31
Completion
2025-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05993247 on ClinicalTrials.gov