Effect of Probiotic Supplementation on Endothelial Function
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): GoodBelly Probiotic; Vancomycin
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 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
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: coronary artery disease; probiotic; endothelial function; brachial artery; ntric oxide