Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02048410

Enrollment

Registered

2014-01-29

Start date

2012-01-31

Completion date

2013-06-30

Last updated

2014-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Familial Hypercholesterolemia

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus paracasei B21060

combination of probiotic (Lactobacillus paracasei B21060) and prebiotics (arabinogalactans, xyloooligosaccarides) and amine (L-glutamine)

OTHERlow satured diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026