Gut Microbiome and Obesity

Overview

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.

Full Title of Study: “Gut Microbiome As Target of Intervention Against Obesity and Metabolic Syndrome”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: May 1, 2022

Interventions

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

Arms, Groups and Cohorts

• Obese subjects
  • Subjects with obesity
• Obese plus metabolic syndrome subjects
  • Subjects with obesity and metabolic syndrome
• Healthy controls
  • Otherwise healthy subjects

Clinical Trial Outcome Measures

Primary Measures

• Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
  • Time Frame: at enrollment
  • Evaluation of gut microbiota composition

Secondary Measures

• Concentration of metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
  • Time Frame: at enrollment
  • Evaluation of butyrate
• Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
  • Time Frame: at enrollment
  • Evaluation of acetate
• Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
  • Time Frame: at enrollment
  • Evaluation of propionate
• Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
  • Time Frame: at enrollment
  • Evaluation of indole

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 16 Years

Investigator Details

• Lead Sponsor
  • Federico II University
• Provider of Information About this Clinical Study
  • Principal Investigator: Roberto Berni Canani, MD, Associate Professor – Federico II University