NCT04247854Unknown不适用
Probiotic Bacillus for Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) in Patients Undergoing Total Joint Arthroplasty: A Randomized, Prospective, Placebo-Controlled Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Persistent Staphylococcus aureus colonization
研究概览
简要总结
This pilot study is designed to determine if ingestion of Bacillus probiotics can cause alteration in levels of S. aureus colonization in the nose and intestine in preoperative orthopedic patients undergoing elective primary TJA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 接受健康志愿者
- 否
入选标准
- •Adults (age >18 years)
- •Undergoing elective primary knee or hip arthroplasty
- •Confirmed colonization of nares and/or rectum with S. aureus or MRSA on routine standard-of-care preadmission testing
- •Written informed consent
排除标准
- •Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment
- •Antibiotic use within 3 months prior to enrollment
- •Active clinical infection
- •Participation in other clinical trials
- •Presence of pregnancy or lactation
结局指标
主要结局
Persistent Staphylococcus aureus colonization
时间窗: post-intervention: following 5 days of dietary supplementation
次要结局
- Changes in microbiome composition(post-intervention: following 5 days of dietary supplementation)
研究者
研究点 (2)
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