This trial is active, not recruiting.

Condition influenza
Treatments fluvax, pcc® (lactobacillus fermentum vri 003)
Phase phase 1/phase 2
Sponsor Probiomics Ltd
Start date March 2006
End date January 2007
Trial size 300 participants
Trial identifier NCT00294788, H05/123, ProFlu2006


This project aims to test the hypothesis that oral consumption of a specific strain of the probiotic bacterium Lactobacillus fermentum (trademarked PCC®) is able to significantly enhance the immune response to a vaccine for influenza.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

The percentage enhancement of the immune response to Fluvax vaccine by PCC® compared to placebo as measured by hemagglutination inhibition (HAI) titre in the serum of subjects 4 weeks after vaccination
time frame:

Secondary Outcomes

Increase in T cell cytokine expression; Decrease in incidence of respiratory tract illness, an improvement in general intestinal health, and a reduction in the severity of adverse side effects of the injection
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 49 years old.

Inclusion Criteria: - Persons must be adult men and women aged 18-49 years (have not reached 50th birthday). - Persons must be able and willing to provide informed consent. - Persons must be willing to receive the influenza vaccine (Fluvax®) given as an intramuscular injection. - Persons must be willing to consume one gelatin capsule per day containing either probiotic bacteria or placebo (inactive substance) for the duration (42 days) of the study. - Persons must be willing to provide blood specimens, each of 10 ml, collected by venepuncture. - Persons must be willing to notify study personnel of a range of health effects by questionnaire. Exclusion Criteria: - Any health condition for which the influenza vaccine is not recommended including: chronic diseases of the pulmonary or cardiovascular systems (including asthma); chronic metabolic diseases (including diabetes); renal dysfunction; hemoglobinopathies; immune deficiency diseases (including HIV infection) or on-going immunosuppressive therapy. - Currently pregnant; nursing mothers; or planning a pregnancy within one month of vaccination. - Allergy to latex, egg, or egg protein, or the antibiotics neomycin or polymyxin. - A prior serious reaction to a vaccine, or have had Guillain-Barre syndrome. - Received an influenza vaccine in the past. - Received any other vaccine within one month prior to enrolment - Are participating in another research study involving any study medication

Additional Information

Official title Phase I/II Placebo-Controlled Study of Consumption of a Probiotic on HAI Titre Following Influenza Vaccination of Healthy Adult Subjects
Principal investigator Ronald Penny, DSc, MD, FRACP
Trial information was received from ClinicalTrials.gov and was last updated in January 2007.
Information provided to ClinicalTrials.gov by Probiomics Ltd.