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NCT01304771 · ClinicalTrials.gov registry record · Phase 1
Safety of Synbiotics as Adjuvant to Influenza Vaccine in Elderly
A Phase 1 study of Influenza, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT01304771: Completed Phase 1 study of Influenza, sponsored by Mayo Clinic.
NCT01304771 is a Phase 1 study of Influenza that has completed, run by Mayo Clinic. The registered enrollment target is 22 participants, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01304771, a Phase 1 study of Influenza, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Synbiotic AKSB
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
What the finished NCT01304771 record still lists
NCT01304771 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which Synbiotic AKSB is the first listed.
NCT01304771 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT01304771 about?
NCT01304771 is a clinical study titled "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 AKS...
What is the current status of trial NCT01304771?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2010-12. Estimated completion is 2011-04.
What conditions does trial NCT01304771 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT01304771?
The interventions under investigation include: Synbiotic AKSB (BIOLOGICAL).
Who is sponsoring clinical trial NCT01304771?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01304771 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01304771's enrollment target sits among peer trials
22 147th of 156 higher than 8 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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