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临床试验/NCT03990350
NCT03990350已完成不适用

Comparison of the Gut Microbiota Composition in Caucasian Hispanic and Caucasian Non-Hispanic Children With and Without Obesity

Nemours Children's Clinic1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2019年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Metagenome of each patient's fecal sample

研究概览

简要总结

The human gastrointestinal (GI) tract is filled with millions of bacteria that can affect our health. These bacteria are linked with our overall health including obesity risk. In the United States the Hispanic population is one of the ethnic groups at higher risk of developing obesity. In this study the team will investigate differences in the GI bacterial composition between Hispanic and Caucasian children, and potentially demonstrate a correlation between the composition of metagenome and a higher risk to develop obesity. This will be done by collecting stool samples and comparing the bacteria found in the stool of Hispanic children (with and without obesity) and Caucasian children (with and without obesity.

详细描述

I. SPECIFIC AIMS There are a vast number of microbes in the human gastrointestinal tract (GI) including bacterial, fungal and protozoal microorganisms which all together make our microbiome. Over the last years evidence has shown that the GI microbiome is linked with our overall health including obesity risk. The GI microbiota can influence both sides of the energy balance that includes factors influencing energy utilization from the diet and factors that play a role in the regulation of energy expenditure and storage by influencing host genes (1, 2). Studies of demonstrated that overweight and obesity rates are among the highest for Hispanic children in the United States. It is estimated that in the US 47% of Hispanic children are overweight and 31% have obesity, compared to 35% and 21% respectively for Caucasian non-Hispanic children. Literature has shown environment factors are associated with childhood obesity in Hispanic children including: parental influences, screen time, physical activity behavior, socioeconomic status/food security, and sleep duration (3,4). Thus far there have been no studies having investigated if there are significant differences in the gut microbiome of Hispanic children; moreover, whether these differences (taxonomy or gene expression) puts them at higher risk to develop obesity compared other ethnic groups.

The investigators predict there are significant GI microbiome differences between Caucasian non-Hispanic children and Hispanic Children.

Aim: Confirm differences in microbiome between Caucasian non-Hispanic children (with and without obesity) and Hispanic children (with and without obesity) in this pilot study.

Hypothesis: Hispanic children will have a lower fecal bacterial diversity compared to Caucasian non-Hispanic children that is associated with more overall adiposity and impaired glucose homeostasis determined by:

A) Next generation metagenomic "whole genome/shotgun" sequencing of DNA from fecal samples of cohorts which includes Hispanic children with obesity, Hispanic children without obesity, Caucasian non-Hispanic children with obesity and Caucasian non-Hispanic children without obesity.

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
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Caucasian non-Hispanic and Hispanic Children with and without obesity.

排除标准

  • if the subject has a current or recent (within the past 14 days) gastrointestinal infection (viral, bacterial, or fungal)
  • Known to have gastrointestinal mucosal disease or have clinically significant constipation.
  • Children taking probiotics.
  • History of antibiotic use within the last 6 months at the time of recruitment.

结局指标

主要结局

Metagenome of each patient's fecal sample

时间窗: through study completion, an average of 9 months

sequence of all bacterial DNA and other organism's DNA in a sample

Food frequency questionnaire

时间窗: through study completion, an average of 9 months

Administer a validated food frequency questionnaire

Physical Activity

时间窗: through study completion, an average of 9 months

Administer a validated physical activity questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Di Guglielmo

Chief, General Pediatrics

Nemours Children's Clinic

研究点 (1)

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