Efficacy of Probiotics for Non-steroidal Anti-inflammatory Drug-induced Enteropathy in Arthritis Patients: A Double-blinded Pilot Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 主要终点
- Changes in the small bowel injuries on capsule endoscopy
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with axial SpA who meet the 2009 ASAS criteria or osteoarthritis diagnosed by hand or foot x-rays
排除标准
- •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)
结局指标
主要结局
Changes in the small bowel injuries on capsule endoscopy
时间窗: From enrollment to the end of treatment at 8 weeks
Changes in the number of ulcers/erosions in the small bowel mucosa on capsule endoscopy before and after taking the NSAIDs and Probiotics/Placebo
次要结局
- 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 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 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)
研究者
Jae Myung Park
Professor
Seoul St. Mary's Hospital