Open Label, Randomized Pilot Study to Examine The Effects of the Probiotic Saccharomyces Boulardii, the Antibiotic Amoxicillin/Clavulanate and the Combination on the Gut Microbiota of Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Gastrointestinal Symptom Rating Scale
研究概览
简要总结
The purpose of this study is to compare and contrast the effects of the probiotic Saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the gut microbiota of healthy volunteers.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 65 years (male or female)
- •Good general health
- •Able to comply with study requirements and to provide informed consent
- •For women of childbearing potential oA negative urine pregnancy test immediately prior to starting the study treatment oAgreement to comply with approved methods of contraception during the period of active study treatment (not required during follow-up)
排除标准
- •History of organ transplantation
- •Known chronic or recurrent systemic disorder associated with immunocompromise
- •A history of allergy or hypersensitivity to Saccharomyces boulardii, brewer's or baker's yeast, amoxicillin, penicillins, or cephalosporins
- •History of severe allergic reaction (requiring hospital admission and/or the administration of parenteral medication or associated with dyspnoea, wheezing, hypotension, loss of consciousness).
- •Oral or systemic antibacterial therapy during the 3 months prior to study enrollment
- •New prescription medications during the 4 weeks prior to study enrollment
- •Prescription, 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 disease
- •Patients with a central venous catheter
- •Patients taking antifungals or laxatives within 14 days of enrolment
- •Patients enrolled in other clinical trials within the past 60 days
- •Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy)
- •History of chronic constipation with passage of fewer than 3 bowel movements per week on average
- •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 (Saccharomyces boulardii)
500 mg, 2 times daily for 14 days
干预措施: Saccharomyces boulardii (Dietary Supplement)
antibiotic (Amoxicillin Clavulanate)
875/125 mg 2 times daily at least 1 hour before meals for 7 days
干预措施: Amoxicillin Clavulanate (Drug)
combination (prebiotic and antibiotic)
Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
干预措施: Saccharomyces boulardii (Dietary Supplement)
combination (prebiotic and antibiotic)
Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
干预措施: Amoxicillin Clavulanate (Drug)
结局指标
主要结局
Gastrointestinal Symptom Rating Scale
时间窗: Day 7
Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms
Gastrointestinal Symptoms Response Score
时间窗: Day 14
Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms
Prevalence of Escherichia in Stool
时间窗: Day -7 to Day 21
Control arm was not assessed as there was no intervention for this group. Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21
Gastrointestinal Symptoms Response Scale
时间窗: Day 21
Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms
Operational Taxonomic Units
时间窗: Day 0 to Day 21
Core Microbiome includes control samples and baseline samples (Day -7 and Day 0) for antibiotic, probiotic, and combination groups. Data for Core microbiome for individual arms are not available. Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21
次要结局
未报告次要终点
研究者
Ciaran Kelly
Professor of Medicine
Beth Israel Deaconess Medical Center