Technical / White Paper

Lactobacillus plantarum PPLP-217: Dossier on Safety, Efficacy and Regulatory Status

Format: PDF file | Document type: Technical / White Paper

Lactobacillus plantarum PPLP-217: Dossier on Safety, Efficacy and Regulatory Status

The L. plantarum​ PPLP-217 clinical dossier includes significant strain specific documentation for supporting health outcomes, as summarized below. Available data supporting L. plantarum​ PPLP-217 includes an infection surveillance study to assess the target area and unmet medical need, the safety, tolerance and long-term persistence/colonization of L. plantarum​ PPLP-217 in the neonatal gut, modulation of the gut microbiota upon administration of L. plantarum​ PPLP-217 and a randomized controlled trial of > 4,500 newborns in rural India showing efficacy in the prevention of sepsis and other infections. Additional clinical documentation supporting early life health outcomes, including prevention of stunting, is also summarized.

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