Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Probiotic Mixture (L. Rhamnosus GG and L. Plantarum 299V) In Pediatric Irritable Bowel Syndrome

NCT07125625

Irritable Bowel Syndrome (IBS)

NOT_YET_RECRUITING NA

Effect of Probiotics on Lipid Management

NCT03952169

Primary Hypercholesterolemia

UNKNOWN NA

The Cholesterol-lowering Efficacy of Probiotic Lactobacillus Plantarum in Hypercholesterolaemic Adults

NCT03263104

Healthy

COMPLETED NA

Administration of a Lactobacillus GG and Vitamins Containing Mixture is Effective in Preventing Nosocomial Infection in Children

NCT02558192

Nosocomial Infection

COMPLETED PHASE3

Effect of Probiotics on Infant's Fecal Microbiota Composition

NCT05524649

Microbial Colonization

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyslipidemia Familial Hypercholesterolemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

diet plus Lactobacillus paracasei B21060

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

Group Type ACTIVE_COMPARATOR

Lactobacillus paracasei B21060

Intervention Type DIETARY_SUPPLEMENT

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

low satured diet

Intervention Type OTHER

low saturated fats diet

Group Type PLACEBO_COMPARATOR

low satured diet

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lactobacillus paracasei B21060

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

Intervention Type DIETARY_SUPPLEMENT

low satured diet

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes