Clinical trial NCT04451148: Gut Microbiome and Obesity
Official title: Gut Microbiome As Target of Intervention Against Obesity and Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity, Childhood
Metabolic Syndrome
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children/adolescents of both sexes, aged between 10-16 years, with obesity, obesity complicated by metabolic syndrome and healthy controls observed at Pediatrics Section of Department of Translational Medical Sciences (University of Naples Federico II)

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
timeFrame: at enrollment
Secondary outcomes:
measure: Concentration of metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
timeFrame: at enrollment
measure: Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
timeFrame: at enrollment
measure: Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
timeFrame: at enrollment
measure: Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
timeFrame: at enrollment
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References: