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PROBESITY-2: Synbiotics in Pediatric Obesity

NCT05162209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2022-01-11

No results posted yet for this study

Summary

The global obesity epidemic presents an unprecedented challenge to the public health worldwide. The factors associated with obesity are complex, and include health behaviours, such as eating habits and daily physical activity, and broader social, environmental and biological determinants that influence these health behaviours. The intestinal microbiota has several beneficial functions related to host health and accumulating evidence indicates that the gut microbiota plays a significant role in the development of obesity, obesity-associated inflammation and insulin resistance. Differences in community composition, functional genes and metabolic activities of the gut microbiota appear to distinguish lean vs obese individuals, suggesting that gut 'dysbiosis' contributes to the development of obesity and/or its complications. Recent studies have suggested some beneficial effects of probiotics and/or prebiotics on obesity and metabolic syndrome in adults; such experience is limited in children and adolescents. There are limited information about the synbiotics in children and adolescent with obesity.The mechanism of action of probotics on obesity are scarce and microbiota restoration/reshaping might be the one. The objective of this study tested the effects of a multispecies synbiotic on anthropometric measurement, glucose metabolism, lipid parameters and intestinal microbiota in children with exogenous obesity.

Conditions

  • Obesity, Childhood
  • Obesity, Adolescent

Interventions

DIETARY_SUPPLEMENT

Synbiotic

Oral sachet, for 12 weeks

Sponsors & Collaborators

  • Eskisehir Osmangazi University

    lead OTHER

Principal Investigators

  • Ener C Dinleyici, MD · Eskisehir Osmangazi University Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2021-04-30
Completion
2021-09-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05162209 on ClinicalTrials.gov