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dc.contributor.authorHaran, John P
dc.contributor.authorPinero, Jose C.
dc.contributor.authorZheng, Yan
dc.contributor.authorPalma, Norma Alonzo
dc.contributor.authorWingertzahn, Mark
dc.date2022-08-11T08:08:10.000
dc.date.accessioned2022-08-23T15:44:51Z
dc.date.available2022-08-23T15:44:51Z
dc.date.issued2021-03-05
dc.date.submitted2021-04-01
dc.identifier.citation<p>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]. <a href="https://doi.org/10.21203/rs.3.rs-275217/v1" target="_blank" title="View preprint on Research Square">Link to preprint on Research Square</a></p>
dc.identifier.doi10.21203/rs.3.rs-275217/v1
dc.identifier.urihttp://hdl.handle.net/20.500.14038/27405
dc.description<p>This article is a preprint. Preprints are preliminary reports of work that have not been certified by peer review.</p>
dc.description.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.
dc.language.isoen_US
dc.relation<p>Now published in Trials, doi:<a href="https://doi.org/10.1186/s13063-021-05157-0" target="_blank" title="view published article">https://doi.org/10.1186/s13063-021-05157-0</a></p>
dc.rightsThis work is licensed under a CC BY 4.0 License.
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectCOVID-19
dc.subjectrandomized controlled study
dc.subjectprotocol
dc.subjectKB109
dc.subjectmicrobiome
dc.subjectsynthetic glycan
dc.subjectBiochemical Phenomena, Metabolism, and Nutrition
dc.subjectBiological Factors
dc.subjectCarbohydrates
dc.subjectDigestive System Diseases
dc.subjectHealth Services Administration
dc.subjectInfectious Disease
dc.subjectMicrobiology
dc.subjectTelemedicine
dc.subjectVirus Diseases
dc.titleVirtualized 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]
dc.typePreprint
dc.source.journaltitleResearch Square
dc.identifier.legacyfulltexthttps://escholarship.umassmed.edu/cgi/viewcontent.cgi?article=1204&amp;context=covid19&amp;unstamped=1
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/covid19/201
dc.identifier.contextkey22287702
refterms.dateFOA2022-08-23T15:44:51Z
html.description.abstract<p>These 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.</p>
dc.identifier.submissionpathcovid19/201
dc.contributor.departmentCenter for Microbiome Research
dc.contributor.departmentDepartment of Microbiology and Physiological Systems
dc.contributor.departmentDepartment of Emergency Medicine


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