Pediatric Obesity Related Metabolite Profile and Gut Microbiota

Obesity, Childhood Clinical Trial

Official title:

Interplay Between Pediatric Obesity Related Plasma Metabolite Profile and Gut Microbiota

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03812497
• Other study ID #: Microbiome and metabolome
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 28, 2018
• Est. completion date: June 28, 2021

Study information

• Verified date: May 2020
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: June 28, 2021
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Individualized Education Program
The every participants will have individualized education program about a way of dietary control and exercise in their usual life.

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The relationship between gut microbiome composition and fecal short chain fatty acid	The relationship between gut microbiome composition and metabolites will be analyzed by canonical correspondence analysis	up to 12 months after enrollment
Primary	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	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