The effect of Lactobacilli on the immune system of healthy adults
| ISRCTN | ISRCTN08280229 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08280229 |
| Secondary identifying numbers | HND-IM-011 |
- Submission date
- 22/09/2011
- Registration date
- 28/09/2011
- Last edited
- 14/07/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English summary of protocol
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
Contact information
Scientific
Boege Allé 10-12
Hoersholm
2970
Denmark
Study information
| Study design | Randomized double-blind placebo-controlled parallel-group multi-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | The study was designed to investigate the immune modulating properties of the probiotic strain L. casei 431® in an influenza vaccination model. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 30/09/2011 |
| Completion date | 30/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | Target number of participants: 1058 subjects, 529 in each arm. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/09/2011 |
| Date of final enrolment | 01/11/2011 |
Locations
Countries of recruitment
- Denmark
- Germany
Study participating centre
2970
Denmark
Sponsor information
Industry
Boege Allé 10-12
Hoersholm
2970
Denmark
| Website | http://www.chr-hansen.com |
|---|---|
"ROR" |
https://ror.org/01mv6bt66 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2015 | Yes | No |
