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

Bambino Gesù Hospital and Research Institute

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: VSL#3 active probiotic; Other: VSL#3 placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01650025

VAIIO

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

VSL#3 placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: VSL#3 placebo

VSL#3 active probiotic

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: VSL#3 active probiotic