Clinical trial NCT03388411: Nutritional Intake and Gut Microbiome
Official title: Nutritional Intake, Metabolic Abnormalities and Gut Microbiome in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Childhood
Keywords: Microbiome
Gut
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 61
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic and community samples

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.


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

Primary outcomes:
measure: Correlation of fecal microbial profile with childhood obesity
timeFrame: visit 1day
measure: Correlation of fecal microbial profile with nutrient intake data using feeding diary
timeFrame: visit 1day
Secondary outcomes:
measure: Correlation of childhood obesity with metabolic abnomalities using blood sampling
timeFrame: visit 1day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
Study officials:
affiliation: Kangnam Sacred Heart Hospital, Hallym University College of Medicine
name: Ky Young Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
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