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Framework for rational donor selection in fecal microbiota transplant clinical trials

Author(s)
Duvallet, Claire; Panchal, Pratik; Budree, Shrish; Osman, Majdi; Alm, Eric J
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Creative Commons Attribution 4.0 International license https://creativecommons.org/licenses/by/4.0/
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Abstract
Early 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.
Date issued
2019-10-10
URI
https://hdl.handle.net/1721.1/124427
Department
Massachusetts Institute of Technology. Department of Biological Engineering; Massachusetts Institute of Technology. Department of Civil and Environmental Engineering
Journal
PloS one
Publisher
Public Library of Science (PLoS)
Citation
Duvalle, Claire et al. "Framework for rational donor selection in fecal microbiota transplant clinical trials." PloS one 14(2019): e022288 © 2019 The Author(s)
Version: Final published version
ISSN
1932-6203
Keywords
General Biochemistry, Genetics and Molecular Biology, General Agricultural and Biological Sciences, General Medicine

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