Effects of VSL#3 on Metabolic, Endocrine, Lipidomic and Inflammatory Parameters of Pediatric Patients With BMI>90°

Study Overview
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Brief Summary
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Obesity in children has become a significant social problem considering that nowadays 4 to 5 % of all children are obese in the industrialized countries with increased incidence in Europe by 10 to 50% over the past 10 years. Obesity is associated with the metabolic syndrome in 30% of the children and is considered as a state of chronic inflammation inducing the production of pro-inflammatory cytokines which determine metabolic and endocrine alterations on the organism. It has been observed that obesity is also linked to a change in the intestinal microflora with a reduction of Bacterioides and bifidobacteria and a decrease of Firmicutes and Staphylococcus aureus. The qualitative and quantitative analysis of the metabolites may provide us with a characterization of the existing phenotypes and variations in relation to the changes of the physiological state, in particular when supplemented or not with a probiotic preparation.

Official Title
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Effects of the Probiotic Preparation VSL#3 on the Metabolic, Endocrine, Lipidomic and Inflammatory Parameters as Well as Variation of the Microbiota in Pediatric Patients With Body Mass Index >90°

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: VSL#3 active probiotic
* Other: VSL#3 placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 6-12 parents or tutors able to give the written consent and follow the study procedures Value of BMI>90° Exclusion Criteria: - Any severe or concomitant clinical or psychiatric condition that, in the investigator's opinion, could affect the treatment, the evaluations and the inclusion in the protocol; Evidence of active liver disease due to other causes; Steroid treatment; immuno suppressive therapies, chemotherapy agents within 2 month from screening; Pregnancy or breastfeeding; Abuse of alcohol and drugs clinically relevant; Diabetes.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: VSL#3 placebo<br>The placebo comparator is administered in the same form and dose as the active ingredient. The patient will take 2 sachets a day for 4 months. | Other: VSL#3 placebo<br> <br> * Other names: placebo;|
| Active Comparator: VSL#3 active probiotic<br>VSL#3 is a probiotic preparation containing 8 different strains of lactic acid bacteria and bifidobacteria. Each sachet contains 450 billion bacteria and the patient will be requested to take 2 sachets a day for 4 months | Dietary Supplement: VSL#3 active probiotic<br> <br> * Other names: VSL#3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effects of VSL#3 on metabolic, endocrine, lipidomic, metabolomic and inflammatory markers and microbiota variation of pediatric patients with BMI>90° |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic, obesity, BMI, metabolic profile, metabolomics