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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01650025
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : January 31, 2017
Information provided by (Responsible Party):
Valerio Nobili, 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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: VSL#3 active probiotic Other: VSL#3 placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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°
Study Start Date : August 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
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.
Other: VSL#3 placebo
Other Name: placebo

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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01650025

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Bambino Gesù Children Hospital
Rome, Italy
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
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Principal Investigator: Valerio Nobili, PhD Bambino Gesù Children Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Valerio Nobili, Pediatrician, Hepatologist, Chief of Hepato-metabolic disease Unit Head of Liver Research Unit, Bambino Gesù Hospital and Research Institute Identifier: NCT01650025    
Other Study ID Numbers: VAIIO
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2016
Keywords provided by Valerio Nobili, Bambino Gesù Hospital and Research Institute:
probiotic, obesity, BMI, metabolic profile, metabolomics
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight