Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00294788




Registration number
NCT00294788
Ethics application status
Date submitted
21/02/2006
Date registered
22/02/2006
Date last updated
9/01/2007

Titles & IDs
Public title
Evaluation of the Safety and Effectiveness of a Probiotic Bacterium to Boost the Immune Response to Influenza Vaccines
Scientific title
Phase I/II Placebo-Controlled Study of Consumption of a Probiotic on HAI Titre Following Influenza Vaccination of Healthy Adult Subjects
Secondary ID [1] 0 0
H05/123
Secondary ID [2] 0 0
ProFlu2006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Fluvax
Treatment: Drugs - PCC® (Lactobacillus fermentum VRI 003)

Other interventions: Fluvax


Treatment: Drugs: PCC® (Lactobacillus fermentum VRI 003)
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Good Health Solutions - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Probiomics Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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 response to a vaccine for influenza.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00294788
Trial related presentations / publications
Mohamadzadeh M, Olson S, Kalina WV, Ruthel G, Demmin GL, Warfield KL, Bavari S, Klaenhammer TR. Lactobacilli activate human dendritic cells that skew T cells toward T helper 1 polarization. Proc Natl Acad Sci U S A. 2005 Feb 22;102(8):2880-5. doi: 10.1073/pnas.0500098102. Epub 2005 Feb 14.
Prescott SL, Dunstan JA, Hale J, Breckler L, Lehmann H, Weston S, Richmond P. Clinical effects of probiotics are associated with increased interferon-gamma responses in very young children with atopic dermatitis. Clin Exp Allergy. 2005 Dec;35(12):1557-64. doi: 10.1111/j.1365-2222.2005.02376.x.
Weston S, Halbert A, Richmond P, Prescott SL. Effects of probiotics on atopic dermatitis: a randomised controlled trial. Arch Dis Child. 2005 Sep;90(9):892-7. doi: 10.1136/adc.2004.060673. Epub 2005 Apr 29.
Qi H, Denning TL, Soong L. Differential induction of interleukin-10 and interleukin-12 in dendritic cells by microbial toll-like receptor activators and skewing of T-cell cytokine profiles. Infect Immun. 2003 Jun;71(6):3337-42. doi: 10.1128/IAI.71.6.3337-3342.2003.
Public notes

Contacts
Principal investigator
Name 0 0
Ronald Penny, DSc, MD, FRACP
Address 0 0
Good Health Solutions
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00294788