drugset / Trial / NCT00620412

Probiotics to Enhance Immunogenicity of Influenza Vaccine in Healthy Adults

NCT00620412

Phase 1 Completed 52 enrolled Tufts Medical Center Amerifit Brands Inc · collab
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2007-09
Primary completion
2008-06
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator FluMist Vaccine 0.1 ml Intranasal

Indications

No indication recorded.