Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

January 28, 2014 updated by: Roberto Berni Canani, Federico II University
Probiotics have been proposed for the treatment of dyslipidemia. the investigators aimed to evaluate efficacy, tolerability and safety of a new symbiotic formulation containing a combination of probiotic and prebiotics and amine in the treatment of children affected by familial hypercholesterolemia (FH).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

FH subjects, aged 6-12 years, consecutively observed a Tertiary Center for Pediatric Nutrition were randomly allocated to two groups of intervention for 6 months: active group, received a low saturated fats diet plus the symbiotic (2.5×109cfu, bid) for 6 months; control group, received low saturated fats diet alone. All children received written indications for low saturated fats diet. The plasmatic lipid profile was assessed by peripheral blood sampling at T0 and T1.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged ≥ 6 and ≤ 12 years.
  • Diagnosis of hypercholesterolemia (LDL cholesterol> 140 mg / dl)
  • Each patient must have shown resistance to dietary therapy lasting at least 6-12 months.

Exclusion Criteria:

  • Age <6 or> 12 years.
  • Patients undergoing drug treatment for hypercholesterolemia.
  • Any medical condition that may interfere with participation in this study
  • Participation in clinical trials still in progress.
  • Taking pre / probiotics for more than 7 days in the 6 months prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: diet plus Lactobacillus paracasei B21060
low saturated fats diet plus the symbiotic (2.5×109cfu, bid)
Dietary supplement: Lactobacillus paracasei B21060
combination of probiotic (Lactobacillus paracasei B21060) and prebiotics (arabinogalactans, xyloooligosaccarides) and amine (L-glutamine)
Other: low satured diet
Placebo Comparator: low saturated fats diet
Other: low satured diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of LDL cholesterol after 6 months of treatment wiyh symbiotic
Time Frame: The plasmatic lipid profile was assessed by peripheral blood sampling at enrollment and after 6 months.
The plasmatic lipid profile was assessed by peripheral blood sampling at enrollment and after 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Investigators

  • Principal Investigator: Roberto berni canani, MD,Phd, university of naples federicoII

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Estimate)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 28, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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