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| Name | Class |
|---|---|
| BioFortis | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | oral consumption, once per day in the morning, fasting, with a glass of water |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis | Nantes | 44200 | France |
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| 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 |
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