Healthy Clinical Trial
Official title:
Double Blind Randomized Controlled Trial to Evaluate the Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) Vs. Placebo in Elderly Subjects Receiving Trivalent Inactivated Influenza Vaccine
This is a phase I, randomized controlled trial to evaluate the safety of Lactobacillus
rhamnosus GG (LGG) versus placebo in elderly subjects receiving the trivalent inactivated
influenza vaccine. Lactobacilli are part of the normal flora of the intestine. LGG is one of
several strains of Lactobacilli that is used as a probiotic or microorganism administered to
confer "health benefits". Our research is focused on studying the possible therapeutic
effects of LGG. The study hypotheses are:
1. LGG or placebo administered twice daily will be safe and well tolerated in elderly
subjects who have just received the trivalent inactivated influenza vaccine
2. The immune response to the influenza vaccine at day 21, 28, 56, and at the end of the
influenza season will be higher in the LGG group than the placebo group
3. The occurrence rate of influenza like illness during the influenza season will be lower
in the LGG group than in the placebo group
4. The diversity of the microbiota in nasopharyngeal and stool specimens at day 21, 28, 56
and at the end of the influenza season will be greater in the LGG group than the
placebo group.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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