Effect of a Mixture of Probiotics on the Antigen Specific Antibody Response in a Influenza Vaccination Model of Healthy Adults
Effect of a Mixture of Probiotics on the Antigen Specific Antibody Response in a Influenza Vaccination Model of Healthy Adults
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.
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.
Inclusion Criteria:

 -  healthy male and female adult

 -  between 18 and 60 years old non menopausal female( with effective contraception)

 -  female non pregnant- not wishing to be pregnat during the study capable to respect the
 protocol

 -  affialted to the social security system aggreeing to be registered in the national
 fileof volunteers

 Exclusion Criteria:

 -  food allergy( component of the experimental product- vaccines)

 -  manifestation of allergy

 -  vaccinated against flu during the 2 previous winters

 -  Food allergy, allergy to one of the component of the experimental products or allergy
 to one of the component of the flu vaccine;

 -  Subject displaying manifestation of allergy or being treated for these;

 -  Subject vaccinated against flu during the 2 previous winter (winter 2009-2010 and
 winter 2010-2011);

 -  Subject who had symptoms evocating flu during the previous winter (winter 2010-2011);

 -  Subject immunodepressed;

 -  Subject with immunomodulatory treatment;

 -  Subject who received a treatment resulting in systemic immunossuppression or local
 immunosuppression at pulmonary level, for at least 1 week during the last 3 months
 before inclusion (V1);

 -  Subject with auto-immune disease;

 -  Subject with inflammatory and chronic diseases;

 -  Subject with on-going antibiotics treatment at the time of the inclusion;

 -  Subject not agree to stop his/her usual probiotics supplementation during the study;

 -  Use of medication which could interfere with the study in the investigator's opinion
 (antibiotics, etc…);

 -  Any health condition for which the influenza vaccine is not recommended;

 -  Subject having received any other vaccine within one month prior to enrolment or
 intent to receive any other vaccination during the study period.