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OpenTrials
Completed

NCT Number: NCT01927107

Effects of Probiotics in Obese Children

The global obesity epidemic presents an unprecedented challenge to the public health worldwide. The factors associated with obesity are complex, and include health behaviors, such as eating habits and daily physical activity, and broader social, environmental and biological determinants that influence these health behaviors. 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. Experimental studies reveal a shift in the abundance of Bacteroidetes and Firmicutes. Presumably, obesity affects the diversity of the gut microbiota and, probably, the way individuals harvest energy from nutrients. 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. The aim of this study was to evaluate potential effects of add-on probiotics to standard therapy on anthropometric measurements, lipid profile and oxidative stress parameters in children.

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Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

he global obesity epidemic presents an unprecedented challenge to the public health worldwide. The factors associated with obesity are complex, and include health behaviors, such as eating habits and daily physical activity, and broader social, environmental and biological determinants that influence these health behaviors. 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. Experimental studies reveal a shift in the abundance of Bacteroidetes and Firmicutes. Presumably, obesity affects the diversity of the gut microbiota and, probably, the way individuals harvest energy from nutrients. 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. The aim of this study was to evaluate potential effects of add-on probiotics to standard therapy on anthropometric measurements, lipid profile and oxidative stress parameters in children.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with obesity according to anthropometric measurements with appropriate weight for age

Exclusion criteria

  • coexistence of secondary obesity, malignancy, immune deficiency, collagen vascular diseases, congenital anomalies, neurological findings, children with receiving concomitant any drugs related chronic condition or antibiotics. Children with exogenous obesity who have also insulin resistance and /or hypertension were also excluded

Treatment and study plan

Probiotics mixture

Dietary Supplement

Comparison of probiotic mixture in addition to standard diet therapy vs. standart diet therapy

Primary outcomes

  1. Obesity related anthropometric measurements

    Time frame: 30th days

    Change of obesity related anthropometric measurements including weight, body mass index, upper arm circumference, tirceps skinfold thickness, waist and hip circumference

Secondary outcomes

  1. Evaluation of biochemical indices and oxidative stress

    Time frame: 30th days

    Serum total cholesterol level, serum triglyceride level, serum LDL-C levels, serum HDL-C levels, serum total anti-oxidant capacity levels, serum total oxidative stress level

  2. Safety

    Time frame: 30th days

    Side effects related with probiotic use: nausea, vomiting, other GIS disturbances, rash

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

Effects of Probiotics Mixture to Standard Diet Therapy in Obese Children

Acronym: Prob-esity

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 22, 2013
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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