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

NCT ID: NCT01849185

Last Updated: 2013-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Food supplement

Intervention Type OTHER

Placebo twice a day for 8 weeks

Placebo twice a day for 8 weeks

Group Type PLACEBO_COMPARATOR

Food supplement

Intervention Type OTHER

Interventions

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Food supplement

Intervention Type OTHER

Other Intervention Names

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BIO-25

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tatiana Berlin, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology Meir MC

Locations

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Division of Cardiology Meir MC

Kfar Saba, , Israel

Site Status

Countries

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Israel

Central Contacts

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Morris Mosseri, MD

Role: CONTACT

97297472587

Tatiana Berlin, MD

Role: CONTACT

97297472587

Other Identifiers

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mmc120213ctil

Identifier Type: -

Identifier Source: org_study_id

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