Status:
UNKNOWN
Evaluation of the Safety and Effectiveness of a Probiotic Bacterium to Boost the Immune Response to Influenza Vaccines
Lead Sponsor:
Probiomics Ltd
Conditions:
Influenza
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
PHASE2
Brief Summary
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00294788
Start Date
March 1 2006
End Date
January 1 2007
Last Update
January 9 2007
Active Locations (1)
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1
Good Health Solutions
Sydney, New South Wales, Australia, 2000