NCT02048410

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

8 months

First QC Date

January 24, 2014

Last Update Submit

January 28, 2014

Conditions

DyslipidemiaFamilial Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

diet plus Lactobacillus paracasei B21060

ACTIVE COMPARATOR

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

Dietary Supplement: Lactobacillus paracasei B21060Other: low satured diet

low saturated fats diet

PLACEBO COMPARATOR

low saturated fats diet

Other: low satured diet

Interventions

Lactobacillus paracasei B21060DIETARY_SUPPLEMENT

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

diet plus Lactobacillus paracasei B21060
low satured dietOTHER
diet plus Lactobacillus paracasei B21060low saturated fats diet

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DyslipidemiasHyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemias

Study Officials

  • Roberto berni canani, MD,Phd

    university of naples federicoII

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,pHd

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 29, 2014

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

June 1, 2013

Last Updated

January 29, 2014

Record last verified: 2014-01