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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
22
AKSB is a novel 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®).
Mayo Clinic
Rochester, Minnesota, United States
number of patients with adverse events
To evaluate the safety and tolerability of AKSB when administered with the influenza vaccine as compared to the influenza vaccine alone with placebo in patients ≥65 years of age.
Time frame: 127 days
Compare stool presence of probiotic enterococcal strain
To evaluate for stool VRE presence pre-post intervention and to compare molecular fingerprinting of VRE isolated with the SF68 strain of enterococci used in the study drug to demonstrate safety of the study drug.
Time frame: baseline to 21 days
Immune response to Influenza A vaccine in the AKSB arm compare to Placebo
To determine whether AKSB can increase the protection rate \[PR, (number of participants that achieve the protective antibody titer)\] by 20% in the AKSB arm at days 14, 28 days and 120 days after vaccination among the elderly patients (≥ 65 years of age). Effect of age (65-75 years and \>75 years), gender, underlying medical history and previous vaccination status (within the last 2 years) will evaluated.
Time frame: days 14, 28 days and 120 days after vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.