Plain English Summary
Background and study aims
It is a challenge to investigate the immune system (bodily process that protects against diseases) in healthy people. Currently, the best method is to vaccinate people and investigate how the immune system reacts. The probiotic (beneficial lactic acid bacteria) investigated in this study has previously been shown to have a beneficial effect on the immune system. The aim of this study is to use the similar vaccination model to study the beneficial effects of the study product on the immune system.
Who can participate?
To take part you need to be aged 18 to 60 years, in general good health.
What does the study involve?
You must consume the study product each day for 6 weeks. The study product is a milk drink containing probiotics, or an identical milk drink without probiotics (placebo). To assess the effect of the probiotics on the immune system, all study participants will be given the seasonal influenza vaccination for 2011-2012. To assess the response to the influenza vaccine blood samples will be collected 4 times during the study. In addition, all study participants should for the three months duration of the study complete a diary on symptoms of common cold and influenza and general quality of life.
What are the possible benefits and risks of participating?
As all participants will receive the seasonal influenza vaccination, a potential benefit of participating in the study is that you may be better protected against influenza during the 2011-2012 influenza season.
The study product is a food product with no adverse effects. The vaccine is the approved seasonal influenza vaccine for 2011-2012 which is considered safe.
Where is the study run from?
The study takes place at Harrison Clinical Research in Munich, Germany and at the University of Copenhagen, Denmark.
When is the study starting and how long is it expected to run for?
The study recruited participants from September to November 2011.
Who is funding the study?
Chr. Hansen A/S is funding the study.
Who is the main contact?
Mrs. Lillian Jespersen
dklij@chr-hansen.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HND-IM-011
Study information
Scientific title
The effect of Lactobacillus paracasei subsp. paracasei, L. casei 431® on immune response to influenza vaccination in healthy adult volunteers: a multi-center, randomized, placebo-controlled, parallel-group study
Acronym
Study hypothesis
The study was designed to investigate the immune modulating properties of the probiotic strain L. casei 431® in an influenza vaccination model.
Ethics approval
1. The Ethical Committee of the Capital Region of Denmark, 12/09/2011, journal number H-1-2011-107
2. The Ethical Committee of the Bayerische Landesärztekammer, 13/09/2011, journal number 11075
Study design
Randomized double-blind placebo-controlled parallel-group multi-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
General immune defence
Intervention
Two different treatment arms are included in the study:
1. A milk drink containing the probiotic strain Lactobacillus paracasei ssp. paracasei, L. casei 431® in a dosage of minimum 1 billion Colony forming units (CFU)/DAY
2. A placebo milk drink
Study products to be taken orally once daily for six weeks.
A seasonal influenza vaccination for 2011/2012 will be given to all subjects after 3 weeks of supplementation with the study product.
Nine weeks follow-up after end of the supplementation phase.
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measure
Haemagglutinin inhibition titers in serum 3 weeks after the vaccination
Secondary outcome measures
Antigen-specific antibody response to the influenza vaccination 3 weeks after the vaccination
Overall trial start date
30/09/2011
Overall trial end date
30/04/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men or women in a general good state of health, age 18-60 years both inclusive
2. Body mass index (BMI) 19-30 kg/m2
3. Provided voluntary written informed consent
4. No antibiotics during the run-in period
5. Subject has been able to abstain from fermented dairy products (such as yoghurts) as well as food and food supplements containing probiotics during the run-in period
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Target number of participants: 1058 subjects, 529 in each arm.
Participant exclusion criteria
1. Chronic immunological disease
2. No cancers within the past five years
3. Influenza vaccination current season or has already suffered from influenza during the current season
4. Acute disease requiring treatment
5. Use of immunosuppressant medication
6. Lactose intolerance or milk protein allergy
7. Hypersensitivity to any of the components of the vaccine
8. Recent complicated gastrointestinal (GI) surgery that may have an impact on GI tract function
9. Oral antibiotics within one month prior to the screening visit
10. Elite athletes
11. Participation in another clinical trial within the past month
12. For pre-menopausal women: pregnant or lactating, or wish to be pregnant during the study and not willing to use reliable contraceptive methods
Recruitment start date
30/09/2011
Recruitment end date
01/11/2011
Locations
Countries of recruitment
Denmark, Germany
Trial participating centre
Boege Allé 10-12
Hoersholm
2970
Denmark
Sponsor information
Organisation
Chr. Hansen A/S (Denmark)
Sponsor details
Boege Allé 10-12
Hoersholm
2970
Denmark
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Chr. Hansen A/S (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25926507