Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

Phase 1

Completed

• Conditions: Dyslipidemia; Familial Hypercholesterolemia
• Interventions: Other: low satured diet; Dietary Supplement: Lactobacillus paracasei B21060

• Registration Number: NCT02048410
• Lead Sponsor: Federico II University

Brief 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).

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2012-09
• Study Completion: 2013-06
• Status Verified: 2014-01
• Study First Submitted: 2014-01-24
• Study First Submitted QC: 2014-01-28
• Last Update Submitted: 2014-01-28
• Study First Posted: 2014-01-29
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low saturated fats diet	low satured diet	low saturated fats diet
diet plus Lactobacillus paracasei B21060	low satured diet	low saturated fats diet plus the symbiotic (2.5×109cfu, bid)
diet plus Lactobacillus paracasei B21060	Lactobacillus paracasei B21060	low saturated fats diet plus the symbiotic (2.5×109cfu, bid)

Primary Outcome Measures

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