Probiotic BIO-25 as a Supplement to Statins for the Treatment of Hypercholesterolemia
Phase 4
- Conditions
- Hypercholesterolemia
- Registration Number
- NCT01849185
- Lead Sponsor
- Meir Medical Center
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- 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
- Patients on chronic antibiotic treatment
- Patients with immune disorders
- Patients who are not receiving maximal dose of statin therapy or receive combination of statins for dyslipidemia.
- Patients who experienced myocardial infarction within less than two months.
- Patients who consume probiotics.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method LDL-Cholesterol levels. 8 weeks The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels.
- Secondary Outcome Measures
Name Time Method Hemoglobin A1C 8 weeks The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycosylated hemoglobin
Trial Locations
- Locations (1)
Division of Cardiology Meir MC
🇮🇱Kfar Saba, Israel
Division of Cardiology Meir MC🇮🇱Kfar Saba, Israel