Efficacy of Probiotics for NSAID-induced Enteropathy in Arthritis Patients

NCT ID: NCT05993247

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-20
• Study Completion Date: 2025-08-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Probiotics arm

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

Group Type: ACTIVE_COMPARATOR

Probiotics capsule

Intervention Type: 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

Placebo arm

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

Group Type: PLACEBO_COMPARATOR

Placebo capsule

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: collaborator

Jae Myung Park

OTHER

Sponsor Role: lead

Responsible Party

Jae Myung Park

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jae Myung Park, MD

Role: STUDY_CHAIR

The Catholic University of Korea

Central Contacts

Jae Myung Park, MD

Role: CONTACT

parkjerry@catholic.ac.kr

+82222586023

Other Identifiers

KC23MISI0269

Identifier Type: -

Identifier Source: org_study_id