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FDA Warning: Gates, J&J-investor backed Probiotic Supplement Causes Sepsis, Preterm Infant Dies

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Staff at TrialSite | Quality Journalism
Oct. 5, 2023, 4:00 p.m.

The U.S. Food and Drug Administration (FDA) now investigates a tragic fatality of a preterm infant who as a result of ingesting live bacteria from a probiotic supplement during hospital care of the mother.  Called Evivo with MCT Oil, the product is manufactured by Infinant Health and is now under a recall.  The FDA issued a warning: don’t use unapproved probiotics for infants.  Previously called Evolve Biosystems, this probiotic product developed out of University of California Davis has been backed by investor heavyweights such as the Bill and Melinda Gates Foundation and Johnson and Johnson’s corporate development/investment arm.

In the warning America’s drug and food regulatory reports are investigating the death of the preterm infant who developed sepsis after ingesting live bacteria from the probiotic supplement.  Genomic sequencing undertaken shows that the bacterium causing the sepsis in the infant was a genetic match to the bacteria in the probiotic.

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