Condition category
Signs and Symptoms
Date applied
08/12/2010
Date assigned
23/12/2010
Last edited
18/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Lillian Jespersen

ORCID ID

Contact details

Boege Allé 10-12
Hoersholm
2970
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HND-IM-001

Study information

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

Acronym

IMPRESS

Study hypothesis

The study was designed to investigate the immune modulating properties of two probiotic strains in an influenza vaccination model.

Ethics approval

Ethical Committee of the Luigi Sacco Hospital in Milan, Italy, approved on the 19th February 2009 (ref: 72/09/101/08/AP)

Study design

Randomised double-blind placebo-controlled parallel-group single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

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

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

Phase

Not Applicable

Drug names

Bifidobacterium animalis ssp. lactis (BB-12®), Lactobacillus paracasei ssp. paracasei (L. casei 431®)

Primary outcome measures

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 trial start date

20/02/2009

Overall trial end date

31/08/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy male and female subjects
2. Aged 20 - 60 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

220 subjects, 55 in each arm

Participant 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

Recruitment start date

20/02/2009

Recruitment end date

31/08/2009

Locations

Countries of recruitment

Italy

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

http://www.chr-hansen.com/

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21899798

Publication citations

  1. Results

    Rizzardini G, Eskesen D, Calder PC, Capetti A, Jespersen L, Clerici M, Evaluation of the immune benefits of two probiotic strains Bifidobacterium animalis ssp. lactis, BB-12® and Lactobacillus paracasei ssp. paracasei, L. casei 431® in an influenza vaccination model: a randomised, double-blind, placebo-controlled study., Br. J. Nutr., 2012, 107, 6, 876-884, doi: 10.1017/S000711451100420X.

Additional files

Editorial Notes