NCT02048410

Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dyslipidemia
• Familial Hypercholesterolemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus paracasei B21060	combination of probiotic (Lactobacillus paracasei B21060) and prebiotics (arabinogalactans, xyloooligosaccarides) and amine (L-glutamine)
OTHER	low satured diet

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-09-01
• Completion: 2013-06-01
• First posted: 2014-01-29
• Last updated: 2014-01-29