Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Simpson's Index of Diversity (Alpha Diversity) in Intestinal Microbiome
研究概览
简要总结
The use of antibiotics has saved millions of human lives, however consumption of antibiotics can select for antibiotic resistant organisms and may lead to changes in commensal microbiome. This study is designed to estimate the effect of antibiotic consumption on microbiome in a rural region of rural Burkina Faso. Changes in the intestinal and nasopharyngeal microbiome and resistome following a short course of antibiotics will be measured.
详细描述
This study is designed to better understand the effect of a short course of antibiotics on changes in intestinal and nasopharyngeal microbiome on treated children and untreated household contacts. The investigators hypothesize that a short course of antibiotics will lead to decreased bacterial diversity shortly after completion of the antibiotic course, and higher probability of identification of bacterial resistance genes in rectal and nasopharyngeal samples. The investigators hypothesize that a 5-day course of antibiotics (azithromycin, amoxicillin, or co-trimoxazole) will lead to significantly decreased intestinal and nasopharyngeal bacterial diversity among children aged 6-59 months.
Specific Aim 1. Determine the effect of treatment with antibiotics on microbiome diversity in children aged 6-59 months following a 5-day course of antibiotics.
Specific Aim 1A. Determine the direct effect of a 5-day course of azithromycin, amoxicillin, or co-trimoxazole on intestinal and nasopharyngeal bacterial diversity in children aged 6-59 months compared to no treatment.
Specific Aim 1B. Determine the indirect effect of antibiotic treatment of children in a household on intestinal and nasopharyngeal bacterial diversity in an untreated child aged 6-59 months.
Specific Aim 1C. Assess the association between intestinal bacterial diversity and anthropometry in a population-based sample of children.
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)
盲法说明
double blind
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Households will be eligible for inclusion in the study if they have 2 or more children aged 6 months to 59 months currently residing in the household. Children from the household will be eligible if they are 6-59 months of age and are not currently receiving antibiotic treatment
排除标准
- •Children who are allergic to any of the study antibiotics will be excluded. Individuals aged under 6 months and 5 years or older will be excluded. Children already receiving antibiotics for an ongoing disease will be excluded.
研究组 & 干预措施
Azithromycin
Comparison of nasopharyngeal and rectal microbiome in children receiving Azithromycin versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm and treated for 5 days.
Children will receive treatment everyday, once a day as is:
Azithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5
干预措施: Azithromycin (Drug)
Amoxicillin
Comparison of nasopharyngeal and rectal microbiome in children receiving Amoxicillin versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.
Children will receive treatment everyday, twice a day as is:
Amoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5
干预措施: Amoxicillin (Drug)
Cotrimoxazole
Comparison of nasopharyngeal and rectal microbiome in children receiving Cotri-moxazole versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.
Children will receive treatment everyday, once a day as is:
Co-trimoxazole: 240 mg daily for Days 1-5
干预措施: Cotrimoxazole (Drug)
Placebo
Comparison of nasopharyngeal and rectal microbiome in children receiving placebo versus children receiving antibiotics Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.
Children will receive Placebo everyday, once a day.
干预措施: Placebo (Drug)
结局指标
主要结局
Simpson's Index of Diversity (Alpha Diversity) in Intestinal Microbiome
时间窗: Baseline and Day 9
The primary outcome of the study was pre-specified as α-diversity (inverse Simpson's) at the genus level, expressed in effective number. Simpson's Alpha Diversity were obtained at Baseline and Post-treatment in this study. The minimum of Simpson's index of diversity is 0, there is no maximum. Higher Simpson's index of diversity means more diverse. There are no subscales.
次要结局
- Simpson's Index of Diversity (Alpha Diversity) in Microbiome(Day 9)
- Weight-for-height Z-score(Day 35)
- Height-for-age Z-score(Day 35)
- L2-norm Distance on Bacterial Reads (Nasopharyngeal)(Day 9)
- Weight-for-age Z-score(Day 35)
- Mid-upper Arm Circumference(Day 35)
- Shannon's Index of Diversity (Alpha Diversity) in Intestinal Microbiome(Baseline and Day 9 (Post- Treatment))
- Shannon's Index of Diversity (Alpha Diversity) in Nasopharyngeal Microbiome(Day 9)
- L1-norm Distance on Bacterial Reads (Intestinal)(Baseline and Day 9 (Post- Treatment))
- L1-norm Distance on Bacterial Reads (Nasopharyngeal)(Day 9)
- Number of Participants With Macrolide Resistance Genes(2 years)
- L2-norm Distance on Bacterial Reads (Intestinal)(Baseline and Day 9 (Post- Treatment))
- Alpha Diversity in the Intestinal Microbiome(2 years)