No evidence of harms of probiotic Lactobacillus rhamnosus GG ATCC 53103 in healthy elderly-a phase I open label study to assess safety, tolerability and cytokine responses.

Acknowledgments The authors would like to acknowledge the hugely significant effort by NIH Program Official Linda Duffy, PhD, MPH, for contributions in structuring the U01 study design, inclusion of validation approaches and biosafety parameters, and implementation of the protocols under phased regulatory approved IND; the clinical and pharmacy staff at Massachusetts General Hospital, the Harvard Catalyst and the CTSA support of the study, the US Food and Drug Administration, Center for Biologics and Evaluation Research (FDA/CBER), Amerifit Brands Inc. for supplying the study product and Chr.

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