CClinicalTrials.gg
Status unknownNCT04451148MATOMSUpdated Jul 7, 2020

Gut Microbiome and Obesity

An observational study in Obesity, Childhood and Metabolic Syndrome, sponsored by Federico II University. Status unknown at 1 site in Italy. Open to participants aged 10 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-07-07.

Sponsored by Federico II University · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
10 Years to 16 Years
Sex
All
01

Study 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.

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Conditions studied

  • Obesity, Childhood
  • Metabolic Syndrome
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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 120 is below the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 16 Years
Sexes eligible
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)

Inclusion criteria

  • Subjects aged between 10-16 years,
  • diagnosis of obesity or obesity complicated by metabolic syndrome
  • healthy controls

Exclusion criteria

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Obese subjects

    Subjects with obesity

    Other: Obese with or without metabolic syndromesubjects

  • Obese plus metabolic syndrome subjects

    Subjects with obesity and metabolic syndrome

    Other: Obese with or without metabolic syndromesubjects

  • Healthy controls

    Otherwise healthy subjects

Interventions

  • OtherObese with or without metabolic syndromesubjects

    Children with obesity and with or without metabolic syndrome

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What researchers measure

Primary outcomes

  1. Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls

    Evaluation of gut microbiota composition

    Time frame: at enrollment

Secondary outcomes

  1. Concentration of metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls

    Evaluation of butyrate

    Time frame: at enrollment

  2. Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls

    Evaluation of acetate

    Time frame: at enrollment

  3. Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls

    Evaluation of propionate

    Time frame: at enrollment

  4. Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls

    Evaluation of indole

    Time frame: at enrollment

07

Study locations

1 of 1 sites recruiting
  • University of Naples Federico II
    Naples, 80131, Italy
    • Roberto Berni Canani, MD, PhD · Contact · berni@unina.it · +390817462680
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04451148
Lead sponsor
Federico II University
Responsible party
Roberto Berni Canani (MD, Associate Professor, Federico II University) — Principal investigator
First posted
Jun 30, 2020
Start date
May 1, 2020
Primary completion
May 1, 2022 (estimated)
Completion
May 1, 2022 (estimated)
Last update
Jul 7, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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