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

Hypercholesterolemia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01849185
• Other study ID #: mmc120213ctil
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 5, 2013
• Last updated: May 7, 2013
• Start date: May 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2013
• Source: Meir Medical Center
• Contact: Morris Mosseri, MD
• Phone: 97297472587
• Email: morris.mosseri[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: clalit health services
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Other:
• Food supplement

Locations

Country	Name	City	State
Israel	Division of Cardiology Meir MC	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Hemoglobin A1C	The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycosylated hemoglobin	8 weeks	No