NCT00294788

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

January 9, 2007

Status Verified

January 1, 2007

First QC Date

February 21, 2006

Last Update Submit

January 8, 2007

Conditions

Influenza

Keywords

InfluenzabioadjuvantprobioticHAIimmunityvaccineImmune response to influenza vaccine

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Interventions

FluvaxBIOLOGICAL
PCC® (Lactobacillus fermentum VRI 003)DRUG

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Health Solutions

Sydney, New South Wales, 2000, Australia

Location

Related Publications (4)

  • 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.

    PMID: 15710900BACKGROUND

  • 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.

    PMID: 16393321BACKGROUND

  • 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.

    PMID: 15863468BACKGROUND

  • 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.

    PMID: 12761116BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Ronald Penny, DSc, MD, FRACP

    Good Health Solutions

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 22, 2006

Study Start

March 1, 2006

Study Completion

January 1, 2007

Last Updated

January 9, 2007

Record last verified: 2007-01

Locations

AU(1)