Effects of Probiotics in Obese Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Probiotics Mixture to Standard Diet Therapy in Obese Children

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Probiotics mixture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic mixture<br>Probiotic mixture including Lactobacillus acidophilus (4.3x108CFU/per sachet), Lactobacillus rhamnosus (4.3x108CFU/ per sachet), Bifidobacterium bifidum (4.3x108CFU/ per sachet), Bifidobacterium longum (4.3x108CFU/ per sachet), Enterococcus faecium (8.2x108CFU/ per sachet, per oral daily for 30 days in addition to standard approach | Dietary Supplement: Probiotics mixture<br>* Comparison of probiotic mixture in addition to standard diet therapy vs. standart diet therapy<br>|
| Active Comparator: Control<br>Standard diet therapy | Dietary Supplement: Probiotics mixture<br>* Comparison of probiotic mixture in addition to standard diet therapy vs. standart diet therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obesity related anthropometric measurements | Change of obesity related anthropometric measurements including weight, body mass index, upper arm circumference, tirceps skinfold thickness, waist and hip circumference | 30th days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of biochemical indices and oxidative stress | 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 | 30th days | 
| Safety | Side effects related with probiotic use: nausea, vomiting, other GIS disturbances, rash | 30th days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, probiotics, oxidative stress