Susceptibility Changes Among Oral Microorganisms Following Single Dose Antibiotic Prophylaxis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Quantitative and qualitative changes in the oral microflora will be determined as well as changes is susceptibility to amoxicillin among these commensals.
研究概览
简要总结
The hypothesis of the present study is that quantitative and qualitative oral microflora alterations and changes in antibiotic susceptibility among oral commensal microflora will occur following a single dose administration of amoxicillin.
详细描述
A total of 33 healthy volunteers, 16 males and 17 females, will be included. Written informed consent will be obtained from all participants.
Subjects will be excluded if they have taken antibiotics within the previous three months, are pregnant, breast-feeding or allergic against penicillin.
The participants will be given a single dose of 2 g amoxicillin. Saliva samples will be collected before administration of antibiotics (day 1) and on day 2, 5, 10, 17 and 24. Un-stimulated saliva will be accumulated in a plastic container. Concentration of amoxicillin in saliva will be measured on day 1, 2 and 5. Samples will be used for the determination of antibiotic concentration. Analyses of the sensitivities to amoxicillin and some other clinically relevant antibiotic compounds will also be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Age 18-45
- •Understands the study procedure and speaks Swedish and/or English
排除标准
- •Treatment with antibiotics within the previous three months
- •Breast-feeding
- •Allergic against penicillin
- •Concomitantly participate in another medical product study
- •Treatment with any kind of medication, health food preparations or probiotics
研究组 & 干预措施
Amoxicillin
All subjects receive one dose of 2 g Amoxicillin
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Quantitative and qualitative changes in the oral microflora will be determined as well as changes is susceptibility to amoxicillin among these commensals.
时间窗: Day 1, 2, 5, 10, 17 and 24
次要结局
- Concentration of amoxicillin in saliva after one dose administration of amoxicillin(Day 1, 2, 5)
研究者
Bodil Lund
Assoc. professor, Dentist
Karolinska University Hospital