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Clinical Trials/NCT03388411
NCT03388411
Completed
Not Applicable

Nutritional Intake, Metabolic Abnormalities and Gut Microbiome in Children

Hallym University Kangnam Sacred Heart Hospital1 site in 1 country61 target enrollmentOctober 18, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity, Childhood
Sponsor
Hallym University Kangnam Sacred Heart Hospital
Enrollment
61
Locations
1
Primary Endpoint
Correlation of fecal microbial profile with childhood obesity
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Pediatric obesity has been increasing in prevalence, but concerns have been raised around the world because no treatment has been found. Recently, however, research on gut microbiome has begun to become a new alternative. It has been shown that changes in the microbiome in adults may induce obesity. However, the results on children are still scarce. Unlike adults, children have few external factors such as alcohol, tobacco, stress, and cancer, making them suitable for obesity-related gut microbiome studies. The investigators will use Illumina MiSeq platform for 16s rRNA metagenomics profiling in children. In this study, the investigators aimed to analyze the relationship between pediatric obesity, gut microbiome profile, blood biomarkers relevant to metabolic syndrome, and nutrient intake data.

Registry
clinicaltrials.gov
Start Date
October 18, 2017
End Date
October 12, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

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

Ky Young Cho

Clinical Professor

Hallym University Kangnam Sacred Heart Hospital

Eligibility Criteria

Inclusion Criteria

  • Obese children: Children ≥95 ‰ between age 7 and 12 years
  • Non-obese children: 5‰\<BMI \<85 ‰ for children between the ages of 7 and 12 years

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

Correlation of fecal microbial profile with childhood obesity

Time Frame: visit 1day

Analysis of fecal microbial profile using 16s rRNA sequencing

Correlation of fecal microbial profile with nutrient intake data using feeding diary

Time Frame: visit 1day

Nutritional intake analysis of total calorie, carbohydrate, fiber, fat, and protein from feeding dairy for two days

Secondary Outcomes

  • Correlation of childhood obesity with metabolic abnomalities using blood sampling(visit 1day)

Study Sites (1)

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