This is a phase I, open label clinical trial to evaluate the safety of Lactobacillus rhamnosus GG (LGG) in elderly subjects. 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: * LGG administered twice daily will be safe and well tolerated in elderly subjects * LGG will colonize the stool of elderly subjects and will modify the diversity and richness of the microbiota in their nasopharyngeal and stool specimens
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
15
1x10\^10 CFU by mouth twice daily for 28 days
Massachusetts General Hospital
Boston, Massachusetts, United States
Occurrence of adverse events that are possibly or probably related to administration of LGG
Adverse events will be detected during study visits with standardized questionnaires, medical history, vital signs, physical examinations, laboratory tests and review of subject diaries as well as between study visits on telephone calls based on responses to adverse event questionnaires.
Time frame: through day 56
Changes in the richness and bacterial diversity of the nasopharyngeal and gut microbiota and presence of LGG in stool specimens by routine culture
We will analyze the stool and nasopharyngeal samples to learn what bacteria are present during different phases of the study and how the types and quantities of bacteria may change over time.
Time frame: through day 56
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