Effects of VSL#3 on Metabolic, Endocrine, Lipidomic and Inflammatory Parameters of Pediatric Patients With BMI>90° (VAIIO)
This study is currently recruiting participants.
Verified November 2012 by Bambino Gesù Hospital and Research Institute
Sponsor:
Bambino Gesù Hospital and Research Institute
Information provided by (Responsible Party):
Valerio Nobili, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier:
NCT01650025
First received: July 23, 2012
Last updated: November 28, 2012
Last verified: November 2012
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Purpose
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 | Intervention |
|---|---|
|
Obesity |
Dietary Supplement: VSL#3 active probiotic |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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° |
Resource links provided by NLM:
Further study details as provided by Bambino Gesù Hospital and Research Institute:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 48 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
|
|
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
|
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650025
Contacts
| Contact: Valerio Nobili, PhD | +393358124175 | nobili66@yahoo.it |
Locations
| Italy | |
| Bambino Gesù Children Hospital | Recruiting |
| Rome, Italy | |
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
Investigators
| Principal Investigator: | Valerio Nobili, PhD | Bambino Gesù Children Hospital |
More Information
No publications provided
| 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 History of Changes |
| Other Study ID Numbers: | VAIIO |
| Study First Received: | July 23, 2012 |
| Last Updated: | November 28, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Bambino Gesù Hospital and Research Institute:
|
probiotic, obesity, BMI, metabolic profile, metabolomics |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013