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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Enhancement of Protective Antibody Response After Probiotic Consumption

Intervention / Treatment
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* Dietary Supplement: Mixture of probiotics
* Dietary Supplement: Mixture of probitiocs


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>oral consumption, once per day in the morning, fasting, with a glass of water | Dietary Supplement: Mixture of probitiocs<br>* effect of the consumption a mixture of probiotics ( dietary supplement tablet - dosage at least 10x7 cfu/g) during 7 weeks , once a day , healthy volonteers ) on the antigen specific antibody respense<br>|
| Experimental: Mixture of probiotics<br>at least 10x7 cfu/tablet of a mixture of probiotics oral consumption, once per day in the morning, fasting, with a glass of water | Dietary Supplement: Mixture of probiotics<br>* effect of the consumption a mixture of probiotics ( dietary supplement tablet - dosage at least 10x7 cfu/g) during 7 weeks , once a day , healthy volonteers ) on the antigen specific antibody respense<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| geographic mean of the increase of antibody titreq against at least one flu strain among the 3 forming the flu vaccine ( H1N1, H3, N and B ) within 3 weeks after flu vaccination |  | inclusion-W 4-W 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seroprotection of the population of volunteers geometric mean of the increase of antibody titres seroprotection in the subset population non sero-protected at V1 |  | inclusion- W4- W7 |