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Probiotics to Enhance Immunogenicity of Influenza Vaccine in Healthy Adults

NCT00620412 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2011-01-19

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Lactobacillus rhamnosus

2 capsules by mouth 2 times a day for 28 days. Each capsule contains 1x10\^10 LGG organisms.

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

Sponsors & Collaborators

  • Amerifit Brands Inc

    collaborator INDUSTRY

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Patricia L Hibberd, MD, PhD · Tufts Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-06-30
Completion
2009-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00620412 on ClinicalTrials.gov