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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| diet plus Lactobacillus paracasei B21060 | Active Comparator | low saturated fats diet plus the symbiotic (2.5×109cfu, bid) |
|
| low saturated fats diet | Placebo Comparator | low saturated fats diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus paracasei B21060 | Dietary Supplement | combination of probiotic (Lactobacillus paracasei B21060) and prebiotics (arabinogalactans, xyloooligosaccarides) and amine (L-glutamine) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto berni canani, MD,Phd | university of naples federicoII | Principal Investigator |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008052 | Lipid Metabolism, Inborn Errors |
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| low satured diet | Other |
|
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |