NCT01650025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

July 23, 2012

Last Update Submit

January 30, 2017

Conditions

Obesity

Keywords

probiotic, obesity, BMI, metabolic profile, metabolomics

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

VSL#3 placebo

PLACEBO COMPARATOR

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

VSL#3 active probiotic

ACTIVE COMPARATOR

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

Interventions

VSL#3 active probioticDIETARY_SUPPLEMENT
Also known as: VSL#3
VSL#3 active probiotic
VSL#3 placeboOTHER
Also known as: placebo
VSL#3 placebo

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age 6-12
  • parents or tutors able to give the written consent and follow the study procedures Value of BMI\>90°

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bambino Gesù Children Hospital

Rome, Italy

Location

Related Publications (1)

  • 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.

    PMID: 24738701DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Valerio Nobili, PhD

    Bambino Gesù Children Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatrician, Hepatologist, Chief of Hepato-metabolic disease Unit Head of Liver Research Unit

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 25, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

January 31, 2017

Record last verified: 2016-01

Locations

IT(1)