Status:
UNKNOWN
Probiotic BIO-25 as a Supplement to Statins for the Treatment of Hypercholesterolemia
Lead Sponsor:
Meir Medical Center
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 examin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01849185
Start Date
May 1 2013
End Date
March 1 2014
Last Update
May 8 2013
Active Locations (1)
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1
Division of Cardiology Meir MC
Kfar Saba, Israel, 44281