Ignite Creation Date:
2024-05-05 @ 11:18 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01304771
Status:
COMPLETED
Last Update Posted:
2012-06-20
First Post:
2010-12-03
Brief Title:
Safety of Synbiotics as Adjuvant to Influenza Vaccine in Elderly
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase I Trial of the Safety and Efficacy of Adjuvant AKSB Agri-King Synbiotic Synbiotic in Patients 65 Years of Age and Older Receiving the Influenza Vaccine
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Probiotics are viable commensal microorganisms that promote the establishment of beneficial microflora Animal and human studies demonstrate that probiotics can enhance bodys 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AT002708-01A1 | NIH | None | httpsreporternihgovquickSearchR21AT002708-01A1 |