Clinical trial NCT05993247: Efficacy of Probiotics for NSAID-induced Enteropathy in Arthritis Patients
Official title: Efficacy of Probiotics for Non-steroidal Anti-inflammatory Drug-induced Enteropathy in Arthritis Patients: A Double-blinded Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Osteoarthritis
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Daewoong Pharmaceutical Co. LTD.
First posted: 2023-08-15
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Probiotics group vs. Placebo group
Primary purpose: PREVENTION

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

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)

Primary outcomes:
measure: Changes in the small bowel injuries on capsule endoscopy
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Change from Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Questionnaire Scores
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Change From Baseline in Symptom Scores on the Western Ontario and McMaster Universities (WOMAC) Arthritis Index
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Change From Baseline in Symptom Scores on the Knee Injury and Osteoarthritis Outcome Scores (KOOS) Questionnaire at 8 Weeks
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Changes in the gut microbiome through Next Generation Sequencing
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: The Catholic University of Korea
name: Jae Myung Park, MD
role: STUDY_CHAIR
References: