Back to resultsProbiotic BIO-25 as a Supplement to Statins for the Treatment of Hypercholesterolemia
Primary Purpose
Hypercholesterolemia
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Food supplement
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hypercholesterolemia
Eligibility Criteria
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:
- 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.
Sites / Locations
- Division of Cardiology Meir MC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
BIO 25 (food supplements)twice a day for 8 weeks
Placebo twice a day for 8 weeks
Arm Description
BIO 25 - Innovative Formula contains 11 different strains of probiotic bacteria patents and more than 25 billion active bacteria in each capsule.
Placebo twice a day for 8 weeks
Outcomes
Primary Outcome Measures
LDL-Cholesterol levels.
The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels.
Secondary Outcome Measures
Hemoglobin A1C
The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycosylated hemoglobin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01849185
Brief Title
Probiotic BIO-25 as a Supplement to Statins for the Treatment of Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BIO 25 (food supplements)twice a day for 8 weeks
Arm Type
Active Comparator
Arm Description
BIO 25 - Innovative Formula contains 11 different strains of probiotic bacteria patents and more than 25 billion active bacteria in each capsule.
Arm Title
Placebo twice a day for 8 weeks
Arm Type
Placebo Comparator
Arm Description
Placebo twice a day for 8 weeks
Intervention Type
Other
Intervention Name(s)
Food supplement
Other Intervention Name(s)
BIO-25
Primary Outcome Measure Information:
Title
LDL-Cholesterol levels.
Description
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 Outcome Measure Information:
Title
Hemoglobin A1C
Description
The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycosylated hemoglobin
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morris Mosseri, MD
Phone
97297472587
Email
morris.mosseri@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana Berlin, MD
Phone
97297472587
Email
tatiana.berlin@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatiana Berlin, MD
Organizational Affiliation
Division of Cardiology Meir MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology Meir MC
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Probiotic BIO-25 as a Supplement to Statins for the Treatment of Hypercholesterolemia
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