Clinical trial NCT03812497: Pediatric Obesity Related Metabolite Profile and Gut Microbiota
Official title: Interplay Between Pediatric Obesity Related Plasma Metabolite Profile and Gut Microbiota
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Childhood
Keywords: Microbiome
Metabolome
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 60
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Intervention arm: every obese children will have individualized education program about diet control and exercise in usual life.

Control arm: normal weight children
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in gut microbiome composition in stool samples
timeFrame: up to 3 months after enrollment
Secondary outcomes:
measure: Changes in short chain fatty acids of fecal samples
timeFrame: up to 12 months after enrollment
Other outcomes:
measure: The relationship between gut microbiome composition and fecal short chain fatty acid
timeFrame: up to 12 months after enrollment
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, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho KY. Lifestyle modifications result in alterations in the gut microbiota in obese children. BMC Microbiol. 2021 Jan 6;21(1):10. doi: 10.1186/s12866-020-02002-3.