Probiotic BIO-25 as a Supplement to Statins for the Treatment of Hypercholesterolemia (no)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01849185
First received: May 5, 2013
Last updated: May 7, 2013
Last verified: May 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01849185     History of Changes
Other Study ID Numbers: mmc120213ctil
Study First Received: May 5, 2013
Last Updated: May 7, 2013
Health Authority: Israel: clalit health services

Keywords provided by Meir Medical Center:
Hypercholesterolemia

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

ClinicalTrials.gov processed this record on July 23, 2014