Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

Federico II University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dyslipidemia; Familial Hypercholesterolemia

Treatments: Dietary Supplement: Lactobacillus paracasei B21060; Other: low satured diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02048410

9/14

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

diet plus Lactobacillus paracasei B21060

Active Comparator group

Description:

low saturated fats diet plus the symbiotic (2.5×109cfu, bid)

Treatment:

Other: low satured diet

Dietary Supplement: Lactobacillus paracasei B21060

low saturated fats diet

Placebo Comparator group

Description:

low saturated fats diet

Treatment:

Other: low satured diet