Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

Dyslipidemia Clinical Trial

Official title:

Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048410
• Other study ID #: 9/14
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 24, 2014
• Last updated: January 28, 2014
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

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

Other:
• low satured diet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No