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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-12-31

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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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VSL#3 placebo

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.

Group Type PLACEBO_COMPARATOR

VSL#3 placebo

Intervention Type OTHER

VSL#3 active probiotic

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

Group Type ACTIVE_COMPARATOR

VSL#3 active probiotic

Intervention Type DIETARY_SUPPLEMENT

Interventions

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VSL#3 active probiotic

Intervention Type DIETARY_SUPPLEMENT

VSL#3 placebo

Intervention Type OTHER

Other Intervention Names

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VSL#3 placebo

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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No