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dc.contributor.authorDuvallet, Claire
dc.contributor.authorPanchal, Pratik
dc.contributor.authorBudree, Shrish
dc.contributor.authorOsman, Majdi
dc.contributor.authorAlm, Eric J
dc.date.accessioned2020-03-30T19:27:43Z
dc.date.available2020-03-30T19:27:43Z
dc.date.issued2019-10-10
dc.identifier.issn1932-6203
dc.identifier.urihttps://hdl.handle.net/1721.1/124427
dc.description.abstractEarly clinical successes are driving enthusiasm for fecal microbiota transplantation (FMT), the transfer of healthy gut bacteria through whole stool, as emerging research is linking the microbiome to many different diseases. However, preliminary trials have yielded mixed results and suggest that heterogeneity in donor stool may play a role in patient response. Thus, clinical trials may fail because an ineffective donor was chosen rather than because FMT is not appropriate for the indication. Here, we describe a conceptual framework to guide rational donor selection to increase the likelihood that FMT clinical trials will succeed. We argue that the mechanism by which the microbiome is hypothesized to be associated with a given indication should inform how healthy donors are selected for FMT trials, categorizing these mechanisms into four disease models and presenting associated donor selection strategies. We next walk through examples based on previously published FMT trials and ongoing investigations to illustrate how donor selection might occur in practice. Finally, we show that typical FMT trials are not powered to discover individual taxa mediating patient responses, suggesting that clinicians should develop targeted hypotheses for retrospective analyses and design their clinical trials accordingly. Moving forward, developing and applying novel clinical trial design methodologies like rational donor selection will be necessary to ensure that FMT successfully translates into clinical impact.en_US
dc.language.isoen
dc.publisherPublic Library of Science (PLoS)en_US
dc.relation.isversionof10.1371/journal.pone.0222881en_US
dc.rightsCreative Commons Attribution 4.0 International licenseen_US
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/en_US
dc.sourcePLoSen_US
dc.subjectGeneral Biochemistry, Genetics and Molecular Biologyen_US
dc.subjectGeneral Agricultural and Biological Sciencesen_US
dc.subjectGeneral Medicineen_US
dc.titleFramework for rational donor selection in fecal microbiota transplant clinical trialsen_US
dc.typeArticleen_US
dc.identifier.citationDuvalle, Claire et al. "Framework for rational donor selection in fecal microbiota transplant clinical trials." PloS one 14(2019): e022288 © 2019 The Author(s)en_US
dc.contributor.departmentMassachusetts Institute of Technology. Department of Biological Engineeringen_US
dc.contributor.departmentMassachusetts Institute of Technology. Department of Civil and Environmental Engineeringen_US
dc.relation.journalPloS oneen_US
dc.eprint.versionFinal published versionen_US
dc.type.urihttp://purl.org/eprint/type/JournalArticleen_US
eprint.statushttp://purl.org/eprint/status/PeerRevieweden_US
dc.date.updated2020-02-10T20:35:46Z
dspace.date.submission2020-02-10T20:35:49Z
mit.journal.volume14en_US
mit.journal.issue10en_US
mit.licensePUBLISHER_CC


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