Effect of Probiotic Supplementation on Endothelial Function
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: GoodBelly Probiotic; Vancomycin
Intervention description: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days; GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Intervention MeSH terms: Vancomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Male
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: coronary artery disease; probiotic; endothelial function; brachial artery; ntric oxide

Summary:

      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.
    

Eligibility criteria:

        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.