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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: VSL#3 active probiotic; Other: VSL#3 placebo

• Registration Number: NCT01650025
• Lead Sponsor: Bambino Gesù Hospital and Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-25
• Study Start: 2012-08
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Status Verified: 2016-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VSL#3 active probiotic	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
VSL#3 placebo	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bambino Gesù Children Hospital; 🇮🇹 Rome, Italy