Clinical trial NCT01652066: Effect of a Mixture of Probiotics on the Antigen Specific Antibody Response in a Influenza Vaccination Model of Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enhancement of Protective Antibody Response After Probiotic Consumption
Lead sponsor: Merck Medication Familiale
Sponsor class: INDUSTRY
Collaborators: name: BioFortis
First posted: 2012-07-27
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: inclusion-W 4-W 7
Secondary outcomes:
measure: seroprotection of the population of volunteers geometric mean of the increase of antibody titres seroprotection in the subset population non sero-protected at V1
timeFrame: inclusion- W4- W7
Other outcomes:
Locations:
city: Nantes
country: France
facility: Biofortis
Study officials:
References: