Funding for this research was provided by:
Centers for Disease Control and Prevention (1U1CI000033 301)
National Institute of Allergy and Infectious Diseases (R01AI123394)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD092414)
National Institutes of Health (TL1 TR000449)
Pediatric Infectious Diseases Society (St. Jude Fellowship in Basic Research)
National Human Genome Research Institute (T32 HG000045)
Received: 21 August 2020
Accepted: 3 February 2021
First Online: 16 February 2021
Ethics approval and consent to participate
: The PUNCH CD study from which the above samples were obtained was approved under US Food and Drug Administration investigational new drug application at 11 medical centers in the USA [CitationRef removed]. Institutional review boards at each center approved the study protocol, and all patients provided informed consent. Secondary microbiome analysis of de-identified fecal samples presented here was deemed non-human subjects research by the Washington University in St. Louis Human Rights Protection Office (HRPO 201409079). Both the clinical trial and this study conformed to the principles of the Helsinki Declaration.
: Not applicable
: Rebiotix, Inc. provided access to study specimens and data and reviewed the manuscript prior to submission, but was not involved in this study’s design, specimen processing, data analysis, or interpretation. Washington University investigators had the final say on published content. Erik R. Dubberke is a consultant for Sanofi, Pfizer, Synthetic Biologics, BioK+, and Rebiotix with grants from Pfizer. The remaining authors declare no other competing interests.