Dyslipidemia Clinical Trial
Official title:
Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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