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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
52
2 capsules by mouth 2 times a day for 28 days. Each capsule contains 1x10\^10 LGG organisms.
2 capsules by mouth twice a day for 28 days
intranasal spray, 0.1ml per nostril, one time dose
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
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
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