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Study to Evaluate the Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) in Elderly Subjects

Healthy Clinical Trial

Official title:
Open Label Study to Evaluate the Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) in Elderly Subjects

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01274598
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Completed
Phase Phase 1
Start date December 2010
Completion date August 2011
View Details
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