Gut Microbiome and Obesity

Metabolic Syndrome Clinical Trial

— MATOMS  

Official title:

Gut Microbiome As Target of Intervention Against Obesity and Metabolic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451148
• Other study ID #: 103/20
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: July 2020
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pediatric obesity is a risk factor for the onset of obesity in adulthood and is a risk factor for various chronic non-communicable diseases. Metabolic syndrome (MS) is the name for a group of risk factors that increase cardiovascular risk and other health problems characterized by the presence of abdominal obesity, dyslipidemia, hyperglycaemia and high blood pressure. Numerous preclinical and clinical data suggest a potential role of the intestinal microbiota in these diseaes. Unfortunately, comparative studies of the gut microbiota are still scarce in pediatric subjects suffering from obesity than obesity complicated by MS. The aim is to study the metagenomics and metabolomics characteristics of the intestinal microbiota in obese children/adolescents with or without MS, that could provide useful data for innovative intervention strategies for these conditions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

Inclusion Criteria:

• Subjects aged between 10-16 years,

• diagnosis of obesity or obesity complicated by metabolic syndrome

• healthy controls

Exclusion Criteria:

• Age at enrollment < 10 or >16 years,

• concomitant presence of chronic diseases,

• neoplasms,

• immunodeficiencies,

• chronic infections,

• autoimmune diseases,

• chronic inflammatory bowel diseases,

• celiac disease, -genetic-metabolic diseases, -

• cystic fibrosis

• chronic lung diseases,

• malformations of the cardiovascular/respiratory/gastrointestinal system,

• neuropsychiatric disorders

• neurological pathologies,

• assumption of antibiotics and/or pre/pro/synbiotics

• onset of diarrhea or acute gastrointestinal disease during the 12 weeks prior to enrollment.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity
• Obesity, Childhood
• Pediatric Obesity
• Syndrome

Intervention

Other:
• Obese with or without metabolic syndromesubjects
Children with obesity and with or without metabolic syndrome

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls	Evaluation of gut microbiota composition	at enrollment
Secondary	Concentration of metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls	Evaluation of butyrate	at enrollment
Secondary	Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls	Evaluation of acetate	at enrollment
Secondary	Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls	Evaluation of propionate	at enrollment
Secondary	Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls	Evaluation of indole	at enrollment