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

Phase 4

• Conditions: Hypercholesterolemia
• Interventions: Other: Food supplement

• Registration Number: NCT01849185
• Lead Sponsor: Meir Medical Center

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-05
• Study Start: 2013-05
• Study First Submitted: 2013-05-05
• Study First Submitted QC: 2013-05-07
• Last Update Submitted: 2013-05-07
• Study First Posted: 2013-05-08
• Last Update Posted: 2013-05-08
• Primary Completion: 2014-01
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo twice a day for 8 weeks	Food supplement	Placebo twice a day for 8 weeks
BIO 25 (food supplements)twice a day for 8 weeks	Food supplement	BIO 25 - Innovative Formula contains 11 different strains of probiotic bacteria patents and more than 25 billion active bacteria in each capsule.

Primary Outcome Measures

Name	Time	Method
LDL-Cholesterol levels.	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

Name	Time	Method
Hemoglobin A1C	8 weeks	The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycosylated hemoglobin

Trial Locations

Locations (1)

Division of Cardiology Meir MC; 🇮🇱 Kfar Saba, Israel