A study to evaluate the immune health benefits of two selected probiotic strains
| ISRCTN | ISRCTN64739181 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64739181 |
| Secondary identifying numbers | HND-IM-001 |
- Submission date
- 08/12/2010
- Registration date
- 23/12/2010
- Last edited
- 18/04/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Lillian Jespersen
Scientific
Scientific
Boege Allé 10-12
Hoersholm
2970
Denmark
Study information
| Study design | Randomised double-blind placebo-controlled parallel-group single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised, double-blind, placebo-controlled trial to evaluate the impact of a minidrink or capsule containing selected probiotic strains on the immune response following an influenza vaccination in healthy adults |
| Study acronym | IMPRESS |
| Study objectives | The study was designed to investigate the immune modulating properties of two probiotic strains in an influenza vaccination model. |
| Ethics approval(s) | Ethical Committee of the Luigi Sacco Hospital in Milan, Italy, approved on the 19th February 2009 (ref: 72/09/101/08/AP) |
| Health condition(s) or problem(s) studied | General immune defence |
| Intervention | Four different treatment arms are included in the study: 1. A capsule containing Bifidobacterium animalis ssp. lactis (BB-12®) in a dosage of minimum 1 billion CFU (colony forming units)/day 2. A placebo capsule 3. A milk-based minidrink containing the probiotic strain Lactobacillus paracasei ssp. paracasei (L. casei 431®) in a dosage of minimum 1 billion CFU/day 4. A placebo minidrink Study products to be taken orally once daily for six weeks. Ten weeks follow-up after end of supplementation phase. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bifidobacterium animalis ssp. lactis (BB-12®), Lactobacillus paracasei ssp. paracasei (L. casei 431®) |
| Primary outcome measure | Antigen-specific response to the influenza vaccination in plasma and saliva 4 weeks after the vaccination. |
| Secondary outcome measures | General adaptive and innate immune responses to the influenza vaccination 4 weeks after the vaccination. |
| Overall study start date | 20/02/2009 |
| Completion date | 31/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 220 subjects, 55 in each arm |
| Key inclusion criteria | 1. Healthy male and female subjects 2. Aged 20 - 60 years old |
| Key exclusion criteria | 1. Presence of acute or terminal disease 2. Gastrointestinal disorders or surgery 3. Intolerance for milk protein or lactose 4. Daily consumption of probiotic products 5. Antibiotic treatment 6. Any vaccination 15 days prior to baseline 7. Prior influenza vaccination for the 2008/2009 season 8. Already having suffered from influenza during the 2008/2009 season |
| Date of first enrolment | 20/02/2009 |
| Date of final enrolment | 31/08/2009 |
Locations
Countries of recruitment
- Denmark
- Italy
Study participating centre
Boege Allé 10-12
Hoersholm
2970
Denmark
2970
Denmark
Sponsor information
Chr. Hansen A/S (Denmark)
Industry
Industry
Boege Allé 10-12
Hoersholm
2970
Denmark
| Website | http://www.chr-hansen.com/ |
|---|---|
"ROR" |
https://ror.org/01mv6bt66 |
Funders
Funder type
Industry
Chr. Hansen A/S (Denmark)
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 | 01/03/2012 | Yes | No |
