Pediatric Obesity Related Metabolite Profile and Gut Microbiota

Study 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.

Official Title
-----------------
Interplay Between Pediatric Obesity Related Plasma Metabolite Profile and Gut Microbiota

Conditions
-----------------
Obesity, Childhood

Intervention / Treatment
-----------------
* Behavioral: Individualized Education Program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obese Children Group<br>To reduce the weight, every obese children will receive individualized education program about a way of dietary control and exercise in their usual life. This individualized education program, developed by investigators, specialized dietitian and exercise teacher, is scheduled once a month. | Behavioral: Individualized Education Program<br>* The every participants will have individualized education program about a way of dietary control and exercise in their usual life.<br>|
| No Intervention: Normal Weight Children Group<br>Normal weight children | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gut microbiome composition in stool samples | Bacterial diversity and composition using 16s rRNA sequencing. Especially Bacteroidetes and Firmicutes populations in fecal microbiome will be analyzed related with obesity. | up to 3 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in short chain fatty acids of fecal samples | The main metabolites produced by gut microbiome, short chain fatty acids using gas chromatography- mass-spectrometry. | up to 12 months after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microbiome, Metabolome