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

Clalit Health Services

Status and phase: Unknown; Phase 4

Conditions: Hypercholesterolemia

Treatments: Other: Food supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01849185

mmc120213ctil

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

BIO 25 (food supplements)twice a day for 8 weeks

Active Comparator group

Description:

BIO 25 - Innovative Formula contains 11 different strains of probiotic bacteria patents and more than 25 billion active bacteria in each capsule.

Treatment:

Other: Food supplement

Placebo twice a day for 8 weeks

Placebo Comparator group

Description:

Placebo twice a day for 8 weeks

Treatment:

Other: Food supplement