Probiotic BIO-25 as a Supplement to Statins for the Treatment of Hypercholesterolemia

Meir Medical Center60 enrolled

Overview

The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels. The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycolysated hemoglobin

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypercholesterolemia

Interventions

Food supplementOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1\) Patients on maximal tolerated dose of conventional statins treated for at least eight weeks on simvastatin 40, pravastatin 40, atorvastatin 40-80 or rosuvastatin 20-40 mg, who failed to achieve target values of LDL-cholesterol according to the European Socety Cardiology guidelines 2012. Exclusion Criteria: 1. Patients on chronic antibiotic treatment 2. Patients with immune disorders 3. Patients who are not receiving maximal dose of statin therapy or receive combination of statins for dyslipidemia. 4. Patients who experienced myocardial infarction within less than two months. 5. Patients who consume probiotics.

Locations (1)

Division of Cardiology Meir MC

Kfar Saba, Israel

Outcomes

Primary Outcomes

LDL-Cholesterol levels.

The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels.

Time frame: 8 weeks

Secondary Outcomes

Hemoglobin A1C

The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycosylated hemoglobin

Time frame: 8 weeks

Central Contacts

Morris Mosseri, MD

CONTACT

97297472587 morris.mosseri@clalit.org.il

Tatiana Berlin, MD

CONTACT

97297472587 tatiana.berlin@clalit.org.il

Data from ClinicalTrials.gov

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