Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gut microbiota structure and function: a structured summary of a study protocol for a randomized controlled study
This study is active and enrollment was completed in January, 2021.K032 protocol version 2, June 30, 2020; recruitment is estimated to start in July, 2020. This study is recruiting and the study is estimated to be completed in March 2021.Study registrationK031 is registered with the US National Library of Medicine, IdentifierNCT04414124 as of June 4, 2020.K032 is registered with the US National Library of Medicine, IdentifierNCT04486482 as of July 24, 2020.Full protocolThe full protocols are attached as additional files (Additional files1 and2), accessible from theClinicalTrials.gov website. In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocols.The study protocols have been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional files3 and4).
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