Efficacy of Probiotics for NSAID-induced Enteropathy in Arthritis Patients

NCT05993247 | Unknown Phase 2

• 1 other identifier: KC23MISI0269
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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 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

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Changes in the small bowel injuries on capsule endoscopy

  Changes in the number of ulcers/erosions in the small bowel mucosa on capsule endoscopy before and after taking the NSAIDs and Probiotics/Placebo

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (4)

• Change from Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Questionnaire Scores

  From enrollment to the end of treatment at 8 weeks

• Change From Baseline in Symptom Scores on the Western Ontario and McMaster Universities (WOMAC) Arthritis Index

  From enrollment to the end of treatment at 8 weeks

• Change From Baseline in Symptom Scores on the Knee Injury and Osteoarthritis Outcome Scores (KOOS) Questionnaire at 8 Weeks

  From enrollment to the end of treatment at 8 weeks

• Changes in the gut microbiome through Next Generation Sequencing

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Probiotics arm

ACTIVE COMPARATOR

Probiotics combination capsule (Bacillus Subtilis 150 mg /Clostridium Burtyricum Toa 150 mg /Saccharomyces Boulardii 113 mg) per oral, three times a day, for 8 weeks

Combination Product: Probiotics capsule

Placebo arm

PLACEBO COMPARATOR

Placebo capsule in the same form as probiotics, per oral, three times a day, for 8 weeks

Combination Product: Placebo capsule

Interventions

Probiotics capsule COMBINATION_PRODUCT

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

Probiotics arm

Placebo capsule COMBINATION_PRODUCT

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

Placebo arm

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with axial SpA who meet the 2009 ASAS criteria or osteoarthritis diagnosed by hand or foot x-rays

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jae Myung Park: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator

MeSH Terms

Conditions

Osteoarthritis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jae Myung Park, MD

  The Catholic University of Korea

  STUDY CHAIR

Central Study Contacts

Jae Myung Park, MD

CONTACT

+82222586023; parkjerry@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Probiotics group vs. Placebo group

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 15, 2023
• Study Start: August 20, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: August 15, 2023

Record last verified: 2023-08