Gut Microbiome and Obesity (MATOMS)

Federico II University

Status

Unknown

Conditions

Obesity, Childhood

Metabolic Syndrome

Treatments

Other: Obese with or without metabolic syndromesubjects

Study type

Observational

Funder types

Other

Identifiers

NCT04451148

103/20

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

10 to 16 years old

Volunteers

No Healthy Volunteers

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.