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

Obesity Clinical Trial

— VAIIO  

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°

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650025
• Other study ID #: VAIIO
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: January 30, 2017
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2016
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• VSL#3 active probiotic

Other:
• VSL#3 placebo

Locations

Country	Name	City	State
Italy	Bambino Gesù Children Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Bambino Gesù Hospital and Research Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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