Working… Menu

Probiotics to Enhance Immunogenicity of Influenza Vaccine in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00620412
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : January 19, 2011
Amerifit Brands Inc
Information provided by:
Tufts Medical Center

Brief Summary:
The purpose of this study is to determine whether the food supplement called Lactobacillus rhamnosus GG (LGG) may help boost the effectiveness of the nasal flu vaccine. Preliminary data from several studies of healthy volunteers suggest that LGG boosts the immune response to vaccines. Fifty-two subjects will be recruited into the study, all will receive the nasal flu vaccine. Twenty-six will receive capsules that contain LGG, 26 will receive placebo capsules. Blood and nasal specimens will be collected weekly for four weeks and at eight weeks to evaluate the initial mucosal and systemic immune response to the immunization. This study will provide preliminary data on whether the immune response of healthy adults to the nasal influenza vaccine can be boosted by LGG.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Lactobacillus rhamnosus Dietary Supplement: placebo control Biological: Influenza Virus Vaccine Live, Intranasal Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lactobacillus GG to Enhance the Immunogenicity of Influenza Vaccine in Healthy Adults - Proof of Concept Study
Study Start Date : September 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: treatment Dietary Supplement: Lactobacillus rhamnosus
2 capsules by mouth 2 times a day for 28 days. Each capsule contains 1x10^10 LGG organisms.
Other Name: Culturelle

Biological: Influenza Virus Vaccine Live, Intranasal
intranasal spray, 0.1ml per nostril, one time dose
Other Name: FluMist

Placebo Comparator: placebo Dietary Supplement: placebo control
2 capsules by mouth twice a day for 28 days

Biological: Influenza Virus Vaccine Live, Intranasal
intranasal spray, 0.1ml per nostril, one time dose
Other Name: FluMist

Primary Outcome Measures :
  1. To measure anti-influenza systemic and mucosal antibody responses 4 weeks after administration of influenza vaccine (LAIV) to healthy subjects aged 18-49 and to compare responses in subjects receiving Lactobacillus GG (LGG) versus placebo [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. To assess time course of antibody response after administration of influenza vaccine (LAIV) and to compare responses in subjects receiving LGG versus placebo [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 18-49 years
  • Available for clinic visits at Tufts-New England Medical Center
  • Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) obtained
  • Ability of participant to understand and comply with the requirements of the protocol

Exclusion Criteria:

  • History of any medical conditions for which the CDC states should not be vaccinated with LAIV (asthma, reactive airways disease, other chronic disorders of the pulmonary or cardiovascular systems; metabolic diseases such as diabetes, renal dysfunction, and hemoglobinopathies; or persons with known or suspected immunodeficiency diseases)
  • Self-reported vaccination with the influenza vaccine for the current influenza season (2007-8); vaccination with any vaccine within the one month period prior to study enrollment or intent to receive any other vaccine during the study period; hypersensitivity to any influenza vaccine components including thimersol or egg or Guillain-Barre syndrome
  • Self-reported treatment with immunomodulator/immunosuppressor drugs (interleukins, corticosteriods (oral or inhaled)), G(M)-CSF in 4 weeks before enrollment or self-reported history of IL-2 administration within 5 years; use of theophylline preparations or warfarin because of the theoretical possibilities of enhanced drug effects and toxicities following influenza vaccination; medication use that might affect the immune response to a vaccine or effects of LGG (no antibiotics during the previous 4 weeks)
  • Current alcohol, substance abuse, or systemic/psychiatric illness that potentially could interfere with compliance and ability to make study visits
  • Health care or day care workers or close contacts with immunosuppressed persons because of the theoretical risk that LAIV could be transmitted to the immunosuppressed person and cause disease, per CDC recommendations
  • Use of LGG or other probiotics in 4 weeks before enrollment. Yogurt consumption is not an exclusion criteria, but subjects will be asked to avoid consumption of other lactobacilli and probiotic organisms during the study period
  • Abnormalities upon physical examination
  • Acute febrile illness on day of intended immunization - immunization deferred until illness resolved
  • Routine laboratory tests outside the limits outlined for this study:

    1. hemoglobin >=11.5g/dL for women; >=13.5 g/dL for men
    2. WBC 3,300-12,000 cells/mm^3
    3. Differential within normal range
    4. Platelets 125,000-550,000 /mm^3
    5. ALT <= upper limit of normal
    6. Serum creatinine <= upper limit of normal
    7. Normal urinalysis (negative glucose, negative or trace protein, and negative or trace hemoglobin)
    8. Negative beta-HCG pregnancy test (urine or serum) for women presumed to be of reproductive potential because LAIV is contraindicated in pregnant women
    9. negative HIV test
    10. negative hepatitis B surface antigen
    11. negative anti-HCV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00620412

Sponsors and Collaborators
Tufts Medical Center
Amerifit Brands Inc
Layout table for investigator information
Principal Investigator: Patricia L Hibberd, MD, PhD Tufts Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Patricia L. Hibberd, MD, PhD, Tufts Medical Center Identifier: NCT00620412    
Other Study ID Numbers: 7142
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 2011
Keywords provided by Tufts Medical Center:
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases