Safety of Lactobacillus Rhamnosus GG Versus Placebo in Elderly Subjects Receiving Live Attenuated Influenza Vaccine

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

May 31, 2013

Study Completion Date

May 31, 2013

Conditions
HealthyInfluenza
Interventions
BIOLOGICAL

Lactobacillus rhamnosus GG ATCC 53103 (LGG)

Study drug capsules (1x10\^10 LGG/capsule) are to be taken orally twice a day every day on an outpatient basis for 28 days

BIOLOGICAL

Placebo

Placebo capsules composed of microcrystalline cellulose are to be taken orally twice a day on an outpatient basis for 28 days.

BIOLOGICAL

Live attenuated influenza vaccine

0.2 mL pre-filled, single use intranasal spray

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
lead

Patricia L. Hibberd

OTHER

NCT01545349 - Safety of Lactobacillus Rhamnosus GG Versus Placebo in Elderly Subjects Receiving Live Attenuated Influenza Vaccine | Biotech Hunter | Biotech Hunter