The unregulated freedom to link the results of a trial done with a specific formulation to a new, different one sold under the same brand name is a further confounding factor. Without consideration of current regulatory and commercial loopholes, assessing harms will be difficult for researchers, physicians, and patients. More stringent regulations mandating full disclosure of the probiotic microorganisms at the strain level (and not just at the species level) and of the origin of the product and manufacturing changes are a prerequisite for proper safety and efficacy reporting.

Harms reporting in randomized controlled trials of interventions aimed at modifying microbiota

Baldassarre M. E.
Conceptualization
2019

Abstract

The unregulated freedom to link the results of a trial done with a specific formulation to a new, different one sold under the same brand name is a further confounding factor. Without consideration of current regulatory and commercial loopholes, assessing harms will be difficult for researchers, physicians, and patients. More stringent regulations mandating full disclosure of the probiotic microorganisms at the strain level (and not just at the species level) and of the origin of the product and manufacturing changes are a prerequisite for proper safety and efficacy reporting.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11586/232828
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