Effect of Probiotic Supplementation on Endothelial Function
Effect of Probiotic Supplementation on Endothelial Function
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.
We plan to recruit 20 patients, men with coronary artery disease, for this single center,
 interventional trial with the Probiotic-GoodBelly followed by Vancomycin. The study includes
 6 total visits. Subjects who pass a phone screen will be invited to a screening visit for
 study eligibility (Visit 1) Informed consent will be reviewed; a unique study number will be
 assigned once written informed consent is obtained (no subject will be assigned more than 1
 allocation number); relevant participant medical history will be recorded including currently
 prescribed medications; anthropometric measurements will be taken (height, weight, and waist
 circumference in metric units) and blood pressure will be recorded (measured in triplicate
 and averaged). Subjects will be allowed to take their blood pressure medication on the
 morning of their screening visit, but not the mornings of any of the other study visits to
 limit the acute influence of these medications on endothelial function. If the potential
 participant qualifies for the study, he will return 1 week after the screen for a study
 visit(Visit 2) where he will turn in his stool sample, undergo initial tests of endothelial
 function and receive 3 week supply of GoodBelly Probiotic. After 3 weeks he will have to
 return (Visit 3) for another 3 week supply of his probiotic. After a total of 6 weeks of
 taking the probiotic he will have to return (Visit 4) with his stool sample. He will be asked
 to fast for 6-8 hours prior to the visit to limit the acute dietary influences on vascular
 endothelial function. During Visit 4, endothelial function will determined by brachial artery
 reactivity testing His stool samples will be collected and blood samples will also be taken
 at this visit for systemic measurements inflammatory markers. If he agrees to the optional
 Vancomycin study. He will return after 4 weeks for (Visit 5). He will be asked to fast for
 6-8 hours prior to the visit to limit the acute dietary influences on vascular endothelial
 function. At Visit 5, endothelial function will determined by brachial artery reactivity
 testing His stool samples will be collected and blood samples will also be taken at this
 visit for systemic measurements inflammatory markers. He will then be given a 10 day supply
 of vancomycin. After 10 days he will return (Visit 6) with his stool sample. At Visit 6,
 endothelial function will determined by brachial artery reactivity testing . His stool
 samples will be collected and blood samples will also be taken at this visit for systemic
 measurements inflammatory markers.
Inclusion Criteria:

 1. Age between 40-75 years old

 2. Male sex

 3. 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)

 Exclusion Criteria:

 1. Unstable angina or myocardial infarction by history, ECG, and/or enzymatic criteria
 within 1 month of enrollment.

 2. 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.

 3. Uncontrolled hypertension with a blood pressure greater than 170/100 mmHg at the
 screening visit.

 4. 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.

 5. Known history of cognitive impairment or inability to follow study procedures

 6. 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.

 7. Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks.

 8. Patients with dosing changes of vasoactive medications and
 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors in the 6 weeks prior to
 enrollment.