Safety of Synbiotics as Adjuvant to Influenza Vaccine in Elderly

Probiotics are viable commensal microorganisms that promote the establishment of beneficial
microflora. Animal and human studies demonstrate that probiotics can enhance body's immune
response to stimuli. Mayo Clinic in conjunction with Agri-King Corporation has developed a
novel synbiotic called AKSB (Agri-King Synbiotic) that contains a probiotic bacterium
(Enterococcus faecium, microencapsulated SF68 or Ventrux ME 30), a probiotic yeast
(Saccharomyces cerevisiae, Lynside® Pro-Lay 1), and a prebiotic (fructo-oligosaccharide
[FOS], NutraFlora®). This phase I placebo-controlled trial of AKSB in normal human
volunteers, over 65 years of age, is designed to study the safety of this probiotic when
patients are also receiving an influenza vaccine. If this study shows that AKSB is safe then
our aim is to do a larger study to see if we can improve influenza vaccine immune response
while taking the probiotic compared to placebo.