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

This study has been completed.
Information provided by (Responsible Party):
Valerio Nobili, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier:
First received: July 23, 2012
Last updated: April 1, 2014
Last verified: November 2012

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.

Condition Intervention
Dietary Supplement: VSL#3 active probiotic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: 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°

Resource links provided by NLM:

Further study details as provided by Bambino Gesù Hospital and Research Institute:

Primary Outcome Measures:
  • Evaluate the effects of VSL#3 on metabolic, endocrine, lipidomic, metabolomic and inflammatory markers and microbiota variation of pediatric patients with BMI>90° [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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.
Active Comparator: 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
Dietary Supplement: VSL#3 active probiotic
Other Name: VSL#3


Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650025

Bambino Gesù Children Hospital
Rome, Italy
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
Principal Investigator: Valerio Nobili, PhD Bambino Gesù Children Hospital
  More Information

No publications provided

Responsible Party: Valerio Nobili, Pediatrician, Hepatologist, Chief of Hepato-metabolic disease Unit Head of Liver Research Unit, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT01650025     History of Changes
Other Study ID Numbers: VAIIO
Study First Received: July 23, 2012
Last Updated: April 1, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Bambino Gesù Hospital and Research Institute:
probiotic, obesity, BMI, metabolic profile, metabolomics

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014