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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01304771
The ClinicalTrials.gov registry entry for NCT01304771 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.