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

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

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.

Study Overview

• Status: Completed
• Conditions: Enhancement of Protective Antibody Response After Probiotic Consumption
• Intervention / Treatment: Dietary supplement: Mixture of probitiocs; Dietary supplement: Mixture of probiotics

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.

• Study Type: Interventional
• Enrollment (Actual): 430
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44200
    • Biofortis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; oral consumption, once per day in the morning, fasting, with a glass of water	Dietary supplement: Mixture of probitiocs; 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
Experimental: Mixture of probiotics; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Merck Medication Familiale
• Collaborators: BioFortis

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 25, 2012
• First Submitted That Met QC Criteria: July 25, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Estimate): July 27, 2012
• Last Update Submitted That Met QC Criteria: July 25, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 2011-A00225-36