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Nutritional Intake and Gut Microbiome

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ClinicalTrials.gov Identifier: NCT03388411
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ky Young Cho, Hallym University Kangnam Sacred Heart Hospital

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.

Condition or disease Intervention/treatment
Obesity, Childhood Diagnostic Test: Gut microbiome profiling

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nutritional Intake, Metabolic Abnormalities and Gut Microbiome in Children
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : October 12, 2018
Estimated Study Completion Date : October 12, 2018

Group/Cohort Intervention/treatment
Obese children
Children ≥95 ‰ between age 7 and 12 years
Diagnostic Test: Gut microbiome profiling
Gut microbial profiling will be done with next-generation sequencing targeting bacterial 16s rRNA genes.
Other Name: 16s metagenomic analysis

Non-obese children
5‰< BMI <85 ‰ for children between the ages of 7 and 12 years
Diagnostic Test: Gut microbiome profiling
Gut microbial profiling will be done with next-generation sequencing targeting bacterial 16s rRNA genes.
Other Name: 16s metagenomic analysis




Primary Outcome Measures :
  1. Correlation of fecal microbial profile with childhood obesity [ Time Frame: visit 1day ]
    Analysis of fecal microbial profile using 16s rRNA sequencing

  2. 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 Outcome Measures :
  1. Correlation of childhood obesity with metabolic abnomalities using blood sampling [ Time Frame: visit 1day ]
    Glucose, AST, ALT, uric acid, triglyceride, HDL-cholesterol, LDL-cholesterol, total cholesterol, insulin, hsCRP, 25(OH)-Vitamin D3, hemoglobin, ferritin, and HbA1c


Biospecimen Retention:   Samples With DNA
Whole blood, serum, stool


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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic and community samples
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388411


Contacts
Contact: Saeam Shin, M.D. 82-2-829-5695 saeam0304@hallym.or.kr

Locations
Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of, 07440
Contact: Saeam Shin, M.D.    82-2-829-5695    saeam0304@hallym.or.kr   
Sponsors and Collaborators
Hallym University Kangnam Sacred Heart Hospital
Investigators
Principal Investigator: Ky Young Cho, M.D. Kangnam Sacred Heart Hospital, Hallym University College of Medicine

Publications:

Responsible Party: Ky Young Cho, Clinical Professor, Hallym University Kangnam Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT03388411     History of Changes
Other Study ID Numbers: Gut microbiome
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study participants will only agree if IPD is not shared.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ky Young Cho, Hallym University Kangnam Sacred Heart Hospital:
Microbiome
Gut

Additional relevant MeSH terms:
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms