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 [preprint]
UMass Chan AffiliationsCenter for Microbiome Research
Department of Microbiology and Physiological Systems
Department of Emergency Medicine
randomized controlled study
Biochemical Phenomena, Metabolism, and Nutrition
Digestive System Diseases
Health Services Administration
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AbstractThese 2 parallel studies (K031 and K032) aim to evaluate the safety of KB109 in addition to supportive self-care (SSC) compared with SSC alone in outpatients with mild to moderate coronavirus disease 2019 (COVID-19). KB109 is a novel synthetic glycan that was formulated to modulate the gut microbiome composition and metabolic output in order to increase beneficial short-chain fatty acid (SCFA) production in the gut. The K031 study is designed to evaluate the safety of KB109 and characterize its impact on the natural progression of COVID-19 in patients with mild to moderate disease. The K032 study is evaluating the effect of KB109 on the gut microbiota structure and function in this same patient population. Additionally, both studies are evaluating measures of health care utilization, quality of life (QOL), laboratory indices, biomarkers of inflammation, and serological measures of immunity in patients who received SSC alone or with KB109. Noteworthy aspects of these outpatient studies include study design measures aimed at limiting in-person interactions to minimize the risk of infection spread, such as use of online diaries, telemedicine, and at-home sample collection.
John P Haran, Jose C Pinero, Yan Zheng et al. 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, 05 March 2021, PREPRINT (Version 1) available at Research Square [https://doi.org/10.21203/rs.3.rs-275217/v1]. Link to preprint on Research Square
Permanent Link to this Itemhttp://hdl.handle.net/20.500.14038/27405
This article is a preprint. Preprints are preliminary reports of work that have not been certified by peer review.
Now published in Trials, doi:https://doi.org/10.1186/s13063-021-05157-0
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