Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

Phase 2CompletedNCT02048410

Federico II University40 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dyslipidemia Familial Hypercholesterolemia

Interventions

Lactobacillus paracasei B21060DIETARY_SUPPLEMENT

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

low satured dietOTHER

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

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