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

NCT ID: NCT01652066

Last Updated: 2012-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-12-31

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.

Conditions

Enhancement of Protective Antibody Response After Probiotic Consumption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

oral consumption, once per day in the morning, fasting, with a glass of water

Group Type: PLACEBO_COMPARATOR

Mixture of probitiocs

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: EXPERIMENTAL

Mixture of probiotics

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioFortis

OTHER

Sponsor Role: collaborator

Merck Medication Familiale

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Biofortis

Nantes, , France

Countries

France

Other Identifiers

2011-A00225-36

Identifier Type: -

Identifier Source: org_study_id