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临床试验/NCT03812497
NCT03812497Unknown不适用

Interplay Between Pediatric Obesity Related Plasma Metabolite Profile and Gut Microbiota

Hallym University Kangnam Sacred Heart Hospital2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2018年6月28日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Change in gut microbiome composition in stool samples

研究概览

简要总结

In this study, the investigators aimed to observe changes in the gut microbial composition before and after the weight-loss intervention, including dietary control and exercise, in obese children. The main metabolites produced by gut microbiome, short chain fatty acids (SCFAs) will be also analysed. The investigators will analyse the change of gut microbiome composition and metabolites related with weight-loss intervention and the relationship between microbiome composition and metabolites.

详细描述

Many recent studies have suggested that dysbiosis of the gut microbiome might related to obesity. There is growing evidence that the composition of gut microbiome changes in childhood obesity compared to normal-weight children, and it is attracting attention as an adjustable environmental factor in obesity treatment. It has been reported that gut microbiome could be changed due to environmental influences such as diet and exercise. In this study, the investigators aimed to observe changes in the gut microbial composition before and after the weight-loss intervention, including dietary control and exercise, in obese children. The main metabolites produced by gut microbiome, short chain fatty acids (SCFAs) would be also analysed to investigate the relationship with gut microbiome and with weight-loss intervention. Intervention is not performed for normal-weight children, and samples from normal-weight children will be used as a control for gut microbiome and biochemical tests.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Obese children: Children ≥95 ‰
  • Non-obese children: 5‰<BMI <85 ‰

排除标准

  • Taking antibiotics, probiotics, or steroids for a month before visit
  • Taking probiotics-like products including yogurt for seven days before visit
  • Having enteritis symptoms including diarrhea for a month before visit
  • Chronic heart disease, chronic bowel disease, chronic liver disease, chronic kidney disease, endocrine disease, genetic diseases or congenital metabolic disorder

结局指标

主要结局

Change in gut microbiome composition in stool samples

时间窗: up to 3 months after enrollment

Bacterial diversity and composition using 16s rRNA sequencing. Especially Bacteroidetes and Firmicutes populations in fecal microbiome will be analyzed related with obesity.

次要结局

  • Changes in short chain fatty acids of fecal samples(up to 12 months after enrollment)

研究者

发起方
Hallym University Kangnam Sacred Heart Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ky Young Cho

Associate professor

Hallym University Kangnam Sacred Heart Hospital

研究点 (2)

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