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Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

NCT02048410 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-01-29

No results posted yet for this study

Summary

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).

Conditions

Interventions

DIETARY_SUPPLEMENT

Lactobacillus paracasei B21060

combination of probiotic (Lactobacillus paracasei B21060) and prebiotics (arabinogalactans, xyloooligosaccarides) and amine (L-glutamine)

OTHER

low satured diet

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Roberto berni canani, MD,Phd · university of naples federicoII

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-09-30
Completion
2013-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02048410 on ClinicalTrials.gov