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Gut Microbiome and Obesity (MATOMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04451148
Recruitment Status : Unknown
Verified July 2020 by Roberto Berni Canani, Federico II University.
Recruitment status was:  Recruiting
First Posted : June 30, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University

Study Description
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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.

Condition or disease Intervention/treatment
Obesity, Childhood Metabolic Syndrome Other: Obese with or without metabolic syndromesubjects

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Gut Microbiome As Target of Intervention Against Obesity and Metabolic Syndrome
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Obese subjects
Subjects with obesity
 Other: Obese with or without metabolic syndromesubjects
Children with obesity and with or without metabolic syndrome
Obese plus metabolic syndrome subjects
Subjects with obesity and metabolic syndrome
 Other: Obese with or without metabolic syndromesubjects
Children with obesity and with or without metabolic syndrome
Healthy controls
Otherwise healthy subjects


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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)
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451148


Locations
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Italy
University of Naples Federico II Recruiting
Naples, Italy, 80131
Contact: Roberto Berni Canani, MD, PhD    +390817462680    berni@unina.it   
Sponsors and Collaborators
Federico II University
More Information
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Responsible Party: Roberto Berni Canani, MD, Associate Professor, Federico II University
ClinicalTrials.gov Identifier: NCT04451148    
Other Study ID Numbers: 103/20
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Metabolic Syndrome
Pediatric Obesity
Syndrome
Disease
Pathologic Processes
Overweight
 Overnutrition
Nutrition Disorders
Body Weight
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases