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临床试验/NCT02413905
NCT02413905已完成不适用

Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition

Institut Hospitalo-Universitaire Méditerranée Infection2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Aerotolerant Odds ratio (AOR)

研究概览

简要总结

The investigators performed two case-control studies in Niger and Senegal analysing fecal microbiota to characterize the specificity of the gut microbiota alteration associated with severe acute malnutrition (SAM).

详细描述

Fecal samples of cases (severe acute malnutrition (SAM) ascertained according to the WHO definition) and controls (asymptomatic healthy children ascertained by clinical and anthropometric criteria) were analysed by v3v4 16S rRNA sequencing, redox and pH measurement and using specific polymerase chain reaction targeting Methanobrevibacter smithii and Bacteroides thetaiotaomicron. Based on the literature and oxydative stress reported in SAM, the investigators tested if the proportion of aerotolerant prokaryotes is increased among gut prokaryotes enriched in SAM in comparison to prokaryotes enriched in controls. The investigators further linked this to fecal redox potential and assessed the total number of bacteria in feces by flux cytometry.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Absence of parent or patient consent, antibiotic administration <2 months before stool collection and insufficient fecal amount. Exclusion criteria for controls included any form of malnutrition, presence of fever, acute respiratory infection (cough), acute or chronic diarrhea in the previous 4 weeks. Symptoms and complications of malnutrition (cough, fever, diarrhoea, vomiting) nor other form of malnutrition (moderate to severe stunting and underweight) were not a reason of exclusion for cases since they are considered as direct consequence and part of severe acute malnutrition.

结局指标

主要结局

Aerotolerant Odds ratio (AOR)

时间窗: 1 day (Participants were not followed as this is a case-contol study only clinical and anthropometric data and fecal samples were collected the day of inclusion)

AOR = (number of aerotolerant prokaryotes enriched in the gut of children with SAM \* number of obligate anaerobic prokaryotes enriched in controls)/(number of aerotolerant prokaryotes enriched in controls \* number of obligate anaerobic prokaryotes enriched in children with SAM)

次要结局

未报告次要终点

研究者

发起方
Institut Hospitalo-Universitaire Méditerranée Infection
申办方类型
Other
责任方
Sponsor

研究点 (2)

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