NCT00620412

Probiotics to Enhance Immunogenicity of Influenza Vaccine in Healthy Adults

Lactobacillus GG to Enhance the Immunogenicity of Influenza Vaccine in Healthy Adults - Proof of Concept Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-06-01
• Completion: 2009-12-01
• First posted: 2008-02-21
• Last updated: 2011-01-19