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Safety of Synbiotics as Adjuvant to Influenza Vaccine in Elderly

NCT01304771 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2012-06-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Synbiotic AKSB

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®).

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Abinash Virk, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01304771 on ClinicalTrials.gov