Enhancement of Protective Antibody Response After Probiotic ConsumptionPROBIMMUNENCT01652066
Effect of a Mixture of Probiotics on the Antigen Specific Antibody Response in a Influenza Vaccination Model of Healthy Adults
A study testing Mixture of probiotics and Mixture of probitiocs in people with Enhancement of Protective Antibody Response After Probiotic Consumption, run by Merck Medication Familiale at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Enhancement of Protective Antibody Response After Probiotic Consumption
- What is being tested?
- Mixture of probiotics and Mixture of probitiocs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 430 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Mixture of probiotics, Mixture of probitiocs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixture of probioticsDietary 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 probitiocsDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | oral consumption, once per day in the morning, fasting, with a glass of water Receives: 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 Receives: Dietary Supplement: Mixture of probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: inclusion- W4- W7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startMay 2011
- Primary completionJul 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhancement of Protective Antibody Response After Probiotic ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Medication Familiale
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652066
- Sponsor's protocol ID
- 2011-A00225-36
- Acronym
- PROBIMMUNE
- Status last verified
- Jul 2012
- First submitted
- 25 Jul 2012
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01652066
- Acronym / sponsor ID
- PROBIMMUNE / 2011-A00225-36
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Merck Medication FamilialeIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- May 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Mixture of probitiocsoral consumption, once per day in the morning, fasting, with a glass of water |
| Mixture of probiotics | Experimental | Dietary Supplement: Mixture of probioticsat least 10x7 cfu/tablet of a mixture of probiotics oral consumption, once per day in the morning, fasting, with a glass of water |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixture of probioticseffect 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 | Dietary supplement | Mixture of probiotics |
| Mixture of probitiocseffect 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 | Dietary supplement | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixture of probiotics and Mixture of probitiocs in people with Enhancement of Protective Antibody Response After Probiotic Consumption, run by Merck Medication Familiale at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2012.