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

• ClinicalTrials.gov Identifier: NCT01650025
• Recruitment Status: Completed
• First Posted: July 25, 2012
• Last Update Posted: January 31, 2017
• Sponsor: Bambino Gesù Hospital and Research Institute
• Information provided by (Responsible Party): Valerio Nobili, Bambino Gesù Hospital and Research Institute

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Locations

Italy

Bambino Gesù Children Hospital

Rome, Italy

Sponsors and Collaborators

Bambino Gesù Hospital and Research Institute

Investigators

• Principal Investigator: Valerio Nobili, PhD; Bambino Gesù Children Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Alisi A, Bedogni G, Baviera G, Giorgio V, Porro E, Paris C, Giammaria P, Reali L, Anania F, Nobili V. Randomised clinical trial: The beneficial effects of VSL#3 in obese children with non-alcoholic steatohepatitis. Aliment Pharmacol Ther. 2014 Jun;39(11):1276-85. doi: 10.1111/apt.12758. Epub 2014 Apr 16.

• 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
• Other Study ID Numbers: VAIIO
• First Posted: July 25, 2012
• 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:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight