Effects of Mushroom Extract, S Boulardii and Amoxicillin on the Human Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Bacteria Prevalence in Stool
研究概览
简要总结
The purpose of this study is to compare and contrast the effects of a prebiotic (Trametes Versicolor), a probiotic (Saccharomyces boulardii) and an antibiotic (amoxicillin) on the gut microbiota of healthy volunteers. It is expected that treatment will result in the rapid and reproducible alterations in fecal microbiota that will spontaneously reverse in the weeks after treatment is discontinued.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 39 years (male or female)
- •Good general health
- •Able to comply with study requirements and to provide informed consent
- •For women of childbearing potential
- •A negative urine pregnancy test immediately prior to starting the study treatment
- •Agreement to comply with approved methods of contraception during the period of active study treatment (not required during follow-up)
排除标准
- •Any diagnosed autoimmune disease
- •History of organ transplantation
- •Known chronic or recurrent systemic disorder associated with immunocompromise
- •A history of allergy or hypersensitivity to mushroom or mushroom extract, brewer's or baker's yeast or to penicillins or cephalosporins (including amoxicillin).
- •History of severe allergic reaction (requiring hospital admission and/or the administration of parenteral medication or associated with dyspnoea, wheezing, hypotension, loss of consciousness).
- •Systemic antibacterial therapy during the 3 months prior to study enrollment
- •New prescription medications during the 4 weeks prior to study enrollment
- •Prescription or OTC medications or supplements that are known to alter gut function or microflora (i.e. acid antisecretory drugs, probiotics) during the 4 weeks prior to study enrollment
- •Active gastrointestinal or metabolic disease
- •Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy)
- •History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily
- •Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol.
研究组 & 干预措施
Prebiotic
干预措施: Trametes versicolor extract (Dietary Supplement)
Probiotic
干预措施: Saccharomyces boulardii (Dietary Supplement)
Antibiotic
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Bacteria Prevalence in Stool
时间窗: Day 0 to 56
The most prevalent bacterial genera within the study population Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Days 10 and 14 After Treatment: Average of Days 21, 28, and 56
次要结局
未报告次要终点
研究者
Ciaran Kelly
Professor of Medicine
Beth Israel Deaconess Medical Center