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临床试验/NCT03032042
NCT03032042撤回4 期

Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

University of California, San Francisco1 个研究点 分布在 1 个国家开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Microbial diversity in the intestinal microbiomes of children aged 1-60 months

研究概览

简要总结

Molecular testing of the gut microbiome and enteric pathogens is rapidly moving beyond targeted PCR testing to next generation sequencing techniques. In addition, the current state of monitoring for soil-transmitted helminth infections is moving increasingly from microscopic techniques to molecular techniques. The targeted PCR test for soil transmitted helminth diagnosis has been validated on stool samples, but not rectal swabs. Bulk stool samples are logistically challenging and time-intensive to collect, thus participation is often far from optimal. Rectal swabs are more efficient and may result in higher participation. In this study, children will be randomized to either albendazole, azithromycin, or both drugs, after which both rectal swabs and bulk stool samples will be collected. The investigators will compare the PCR test for soil transmitted helminth infections using both the rectal swabs and the bulk stool samples. In addition, the investigators will analyze the gut microbiome of the children using next generation sequencing techniques to gain insight into effects of mass drug administration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • all children 0 to 5 (up to 6th birthday)

排除标准

  • individuals with a macrolide allergy
  • refusal of parent/guardian

研究组 & 干预措施

albendazole at day 0, azithromycin at day 7

Experimental

干预措施: Albendazole (Drug)

azithromycin at day 0, albendazole at day 7

Experimental

干预措施: Azithromycin (Drug)

albendazole at day 0, azithromycin at day 0

Experimental

干预措施: Azithromycin (Drug)

albendazole at day 0, azithromycin at day 0

Experimental

干预措施: Albendazole (Drug)

Delayed treatment

Other

albendazole at day 7, azithromycin at day 7

干预措施: Delayed treatment (Drug)

结局指标

主要结局

Microbial diversity in the intestinal microbiomes of children aged 1-60 months

时间窗: Day 7

Microbiota diversity in the intestinal microbiomes of children aged 1-60 months in azithromycin-treated, albendazole-treated, azithromycin+albendazole-treated and delayed treatment arms using phylogenetic distance measures

次要结局

  • Sensitivity of Soil-transmitted helminth infection detection in rectal swab versus bulk stool sample in children 0-5(Day 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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