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

Merck KGaA (EMD Serono)

Status

Completed

Conditions

Enhancement of Protective Antibody Response After Probiotic Consumption

Treatments

Dietary Supplement: Mixture of probiotics

Dietary Supplement: Mixture of probitiocs

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01652066

2011-A00225-36

Details and patient eligibility

About

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.

Full 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.

Enrollment

430 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.