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Gut Microbiome and Obesity

Gut Microbiome As Target of Intervention Against Obesity and Metabolic Syndrome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04451148
Acronym
MATOMS
Enrollment
120
Registered
2020-06-30
Start date
2020-05-01
Completion date
2022-05-01
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Obesity, Childhood

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.

Interventions

OTHERObese with or without metabolic syndromesubjects

Children with obesity and with or without metabolic syndrome

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 16 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controlsat enrollmentEvaluation of gut microbiota composition

Secondary

MeasureTime frameDescription
Concentration of metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controlsat enrollmentEvaluation of butyrate
Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controlsat enrollmentEvaluation of acetate

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026