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Completed

NCT Number: NCT01650025

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bambino Gesù Children Hospital

Rome, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VSL#3 active probiotic

Dietary Supplement

Other names: VSL#3

VSL#3 placebo

Other

Other names: placebo

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°

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Bambino Gesù Hospital and Research Institute

Other

Registry information

Official study 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°

Acronym: VAIIO

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 25, 2012
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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