Effect of Probiotic Supplementation on Endothelial Function

Completed · Phase 4

Conditions studied: Coronary Artery Disease

In brief

The study is being performed to determine whether probiotics (GoodBelly) improves blood vessel function.Probiotics similar to yogurt are living micro-organisms (beneficial to its host) the lives in the intestine. Patients who have coronary artery disease will be enrolled in this study. The research results will be used to determine if the type of bacteria present in the intestines play a role in the pathogenesis of cardiovascular disease. Patients with coronary artery disease will be enrolled for up to 12 weeks. Patients will take the probiotic for 6 weeks. Following the 6 week period there is a washout period of 4 weeks, and an optional antibiotic study called vancomycin. Patients will take the vancomycin for 10 days. Blood vessel function will be measured by ultrasound before and after the probiotic supplement and vancomycin antibiotic. Blood will also be taken before and after to evaluate for markers of inflammation.

Key facts

Study ID

NCT01952834

Run by

Medical College of Wisconsin

People needed

21

Starts

2013-06-01

Expected to finish

2015-03-01

Last updated by the study team

2016-01-21

Who can join

Age: 40 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Age between 40-75 years old
• Male sex
• History of known coronary artery disease (by either history of myocardial infarction, angiogram demonstrative >=50% stenosis in at least 1 major epicardial coronary artery, or a previous stress test that showed evidence of ischemia that has not been revealed to be a false positive test by angiography)

You may not qualify if…

• Unstable angina or myocardial infarction by history, ECG, and/or enzymatic criteria within 1 month of enrollment.
• Left ventricular dysfunction as defined by an left ventricular ejection fraction documented as < 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging.
• Uncontrolled hypertension with a blood pressure greater than 170/100 mmHg at the screening visit.
• Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment.
• Known history of cognitive impairment or inability to follow study procedures
• Patient with an implanted defibrillator or permanent pacemaker on with the potential participant is known to rely upon for greater than 50% of ventricular depolarizations.
• Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks.
• Patients with dosing changes of vasoactive medications and 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors in the 6 weeks prior to enrollment.

Where it is running

• Medical College of Wisconsin — Milwauke, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.