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Completed

NCT Number: NCT02048410

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).

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Key information

Conditions

Dyslipidemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Familial Hypercholesterolemia Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus paracasei B21060

Dietary Supplement

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

low satured diet

Other

Primary outcomes

  1. change of LDL cholesterol after 6 months of treatment wiyh symbiotic

    Time frame: The plasmatic lipid profile was assessed by peripheral blood sampling at enrollment and after 6 months.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jan 29, 2014
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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