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

NCT01652066 | Completed

• 1 other identifier: 2011-A00225-36
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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.

Conditions

Enhancement of Protective Antibody Response After Probiotic Consumption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Mixture of probitiocs

Mixture of probiotics

EXPERIMENTAL

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

Interventions

Mixture of probiotics 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

Mixture of probitiocs 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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 with auto-immune disease;
• Subject with inflammatory and chronic diseases;
• 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.

Sponsors & Collaborators

• Merck Medication Familiale: lead
• BioFortis: collaborator

Study Sites (1)

Biofortis

Nantes, 44200, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 27, 2012
• Study Start: May 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 27, 2012

Record last verified: 2012-07

Locations

FR (1)