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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01849185
First Posted: May 8, 2013
Last Update Posted: May 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose

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


Condition Intervention Phase
Hypercholesterolemia Other: Food supplement Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • LDL-Cholesterol levels. [ Time Frame: 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:
  • Hemoglobin A1C [ Time Frame: 8 weeks ]
    The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycosylated hemoglobin


Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BIO 25 (food supplements)twice a day for 8 weeks
BIO 25 - Innovative Formula contains 11 different strains of probiotic bacteria patents and more than 25 billion active bacteria in each capsule.
Other: Food supplement
Other Name: BIO-25
Placebo Comparator: Placebo twice a day for 8 weeks
Placebo twice a day for 8 weeks
Other: Food supplement
Other Name: BIO-25

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849185


Contacts
Contact: Morris Mosseri, MD 97297472587 morris.mosseri@clalit.org.il
Contact: Tatiana Berlin, MD 97297472587 tatiana.berlin@clalit.org.il

Locations
Israel
Division of Cardiology Meir MC
Kfar Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Tatiana Berlin, MD Division of Cardiology Meir MC
  More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01849185     History of Changes
Other Study ID Numbers: mmc120213ctil
First Submitted: May 5, 2013
First Posted: May 8, 2013
Last Update Posted: May 8, 2013
Last Verified: May 2013

Keywords provided by Meir Medical Center:
Hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases