Status:
UNKNOWN
Gut Microbiome and Obesity
Lead Sponsor:
Federico II University
Conditions:
Obesity, Childhood
Metabolic Syndrome
Eligibility:
All Genders
10-16 years
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 fac...
Eligibility Criteria
Inclusion
- Subjects aged between 10-16 years,
- diagnosis of obesity or obesity complicated by metabolic syndrome
- healthy controls
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04451148
Start Date
May 1 2020
End Date
May 1 2022
Last Update
July 7 2020
Active Locations (1)
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1
University of Naples Federico II
Naples, Italy, 80131