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Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

Primary Purpose

Dyslipidemia, Familial Hypercholesterolemia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Lactobacillus paracasei B21060
low satured diet
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    diet plus Lactobacillus paracasei B21060

    low saturated fats diet

    Arm Description

    low saturated fats diet plus the symbiotic (2.5×109cfu, bid)

    low saturated fats diet

    Outcomes

    Primary Outcome Measures

    change of LDL cholesterol after 6 months of treatment wiyh symbiotic

    Secondary Outcome Measures

    Full Information

    First Posted
    January 24, 2014
    Last Updated
    January 28, 2014
    Sponsor
    Federico II University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02048410
    Brief Title
    Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia
    Official Title
    Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    September 2012 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federico II University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslipidemia, Familial Hypercholesterolemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    diet plus Lactobacillus paracasei B21060
    Arm Type
    Active Comparator
    Arm Description
    low saturated fats diet plus the symbiotic (2.5×109cfu, bid)
    Arm Title
    low saturated fats diet
    Arm Type
    Placebo Comparator
    Arm Description
    low saturated fats diet
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Lactobacillus paracasei B21060
    Intervention Description
    combination of probiotic (Lactobacillus paracasei B21060) and prebiotics (arabinogalactans, xyloooligosaccarides) and amine (L-glutamine)
    Intervention Type
    Other
    Intervention Name(s)
    low satured diet
    Primary Outcome Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Roberto berni canani, MD,Phd
    Organizational Affiliation
    university of naples federicoII
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

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