Gut Microbiome and Obesity

NCT ID: NCT04451148

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2022-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity, Childhood Metabolic Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Obese subjects

Subjects with obesity

Obese with or without metabolic syndromesubjects

Intervention Type OTHER

Children with obesity and with or without metabolic syndrome

Obese plus metabolic syndrome subjects

Subjects with obesity and metabolic syndrome

Obese with or without metabolic syndromesubjects

Intervention Type OTHER

Children with obesity and with or without metabolic syndrome

Healthy controls

Otherwise healthy subjects

No interventions assigned to this group

Interventions

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Obese with or without metabolic syndromesubjects

Children with obesity and with or without metabolic syndrome

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Roberto Berni Canani

MD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Naples Federico II

Naples, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Roberto Berni Canani, MD, PhD

Role: primary

+390817462680

Other Identifiers

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103/20

Identifier Type: -

Identifier Source: org_study_id

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