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

This study has been completed.
Sponsor:
Collaborator:
BioFortis
Information provided by (Responsible Party):
Merck Medication Familiale
ClinicalTrials.gov Identifier:
NCT01652066
First received: July 25, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Enhancement of Protective Antibody Response After Probiotic Consumption
Dietary Supplement: Mixture of probiotics
Dietary Supplement: Mixture of probitiocs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Merck Medication Familiale:

Primary Outcome Measures:
  • 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 [ Time Frame: inclusion-W 4-W 7 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • seroprotection of the population of volunteers geometric mean of the increase of antibody titres seroprotection in the subset population non sero-protected at V1 [ Time Frame: inclusion- W4- W7 ] [ Designated as safety issue: Yes ]

Enrollment: 430
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652066

Locations
France
Biofortis
Nantes, France, 44200
Sponsors and Collaborators
Merck Medication Familiale
BioFortis
  More Information

No publications provided

Responsible Party: Merck Medication Familiale
ClinicalTrials.gov Identifier: NCT01652066     History of Changes
Other Study ID Numbers: 2011-A00225-36
Study First Received: July 25, 2012
Last Updated: July 25, 2012
Health Authority: France: 'AFSSAPS'
France: 'CPP'

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014