Probiotic BIO-25 as a Supplement to Statins for the Treatment of Hypercholesterolemia
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2013
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 5, 2013
CompletedFirst Posted
Study publicly available on registry
May 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedMay 8, 2013
May 1, 2013
8 months
May 5, 2013
May 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDL-Cholesterol levels.
The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels.
8 weeks
Secondary Outcomes (1)
Hemoglobin A1C
8 weeks
Study Arms (2)
BIO 25 (food supplements)twice a day for 8 weeks
ACTIVE COMPARATORBIO 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
PLACEBO COMPARATORPlacebo twice a day for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- \) 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology Meir MC
Kfar Saba, 44281, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tatiana Berlin, MD
Division of Cardiology Meir MC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2013
First Posted
May 8, 2013
Study Start
May 1, 2013
Primary Completion
January 1, 2014
Study Completion
March 1, 2014
Last Updated
May 8, 2013
Record last verified: 2013-05