Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-01-04 @ 3:14 AM
Study NCT ID:
NCT01652066
Status:
COMPLETED
Last Update Posted:
2012-07-27
First Post:
2012-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Mixture of Probiotics on the Antigen Specific Antibody Response in a Influenza Vaccination Model of Healthy Adults
Sponsor:
Merck Medication Familiale
Organization:
Study Overview
Official Title:
Effect of a Mixture of Probiotics ( Lactobacillus Gasseri PA16/8,Bifidobacterium Longum SP07/3, Bifidobacterium Bifidum MF 20/5) on the Antigen Specific Antibody Response in a Influenza Vaccination Model of Healthy Adult
Status:
COMPLETED
Status Verified Date:
2012-07
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:
PROBIMMUNE
Brief Summary:
the aim of the study is to get evidence for an enhancement of immune status in subjects after probiotics mixture consumption ( lactobacillus gasseri PA 16/8, Bifidobacterrium longum SP 07/3, Bifidobacterium bifidum MF 20/5) based on influenza vaccination model - compared to placebo.
Detailed Description:
probiotics are "live microorganisms which when administered in adequate amounts confer a health benefit on the host" . many health effects are associated with probiotics , but various degrees of evidence support the benefits associated to probiotics consumption . Impact on defences and the immune system has been shown with several strains and this may result in improved protection against some infections or improvment of vaccine efficacy .
In its scientific requirments for health claims related to immune function, EFSA indicates that it is generally accepted that higher vaccination responses are beneficial.
In its scientific requirments for health claims related to immune function, EFSA indicates that it is generally accepted that higher vaccination responses are beneficial.
Study Oversight
Has Oversight DMC:
False
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?: