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Clinical Trials/NCT03812497
NCT03812497
Unknown
Not Applicable

Interplay Between Pediatric Obesity Related Plasma Metabolite Profile and Gut Microbiota

Hallym University Kangnam Sacred Heart Hospital1 site in 1 country60 target enrollmentJune 28, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity, Childhood
Sponsor
Hallym University Kangnam Sacred Heart Hospital
Enrollment
60
Locations
1
Primary Endpoint
Change in gut microbiome composition in stool samples
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 28, 2018
End Date
June 28, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Hallym University Kangnam Sacred Heart Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ky Young Cho

Associate professor

Hallym University Kangnam Sacred Heart Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change in gut microbiome composition in stool samples

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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