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2092 A multicenter study of fecal microbiota transplantation for Clostridium difficile infection in children

Published online by Cambridge University Press:  21 November 2018

Maribeth R. Nicholson ,
Erin Alexander ,
Mark Bartlett ,
Penny Becker ,
Zev Davidovics ,
Elizabeth E. Knackstedt ,
Michael Docktor ,
Michael Dole ,
Grace Felix  and
Jonathan Gisser
...Show all authors
Maribeth R. Nicholson
Affiliation:
Johns Hopkins Children’s Center, Baltimore, MD, USA Nationwide Children’s Hospital, Columbus, OH, USA Inova Children’s Hospital, Falls Church, VA, USA Primary Children’s Hospital at University of Utah, Salt Lake City, UT, USA MassGeneral Hospital for Children, Boston, MA, USA Children’s Hospital of Philadelphia, Philadelphia, PA, USA Mayo Clinic, Rochester, MN, USA Boston Children’s Hospital, Boston, MA, USA Children’s Center for Digestive Healthcare at Children’s Healthcare of Atlanta, Atlanta, GA, USA University of Southern California, Los Angeles, CA, USA University of Chicago, Chicago, IL, USA Baylor College of Medicine, Houston, TX, USA Cedars Sinai Medical Center, Los Angeles, CA, USA Weill Cornell Medicine, New York, NY, USA Seattle Children’s Hospital at University of Washington, Seattle, WA, USA Medical College of Wisconsin, Milwaukee, WI, USA
Erin Alexander
Affiliation:
Johns Hopkins Children’s Center, Baltimore, MD, USA Nationwide Children’s Hospital, Columbus, OH, USA Inova Children’s Hospital, Falls Church, VA, USA Primary Children’s Hospital at University of Utah, Salt Lake City, UT, USA MassGeneral Hospital for Children, Boston, MA, USA Children’s Hospital of Philadelphia, Philadelphia, PA, USA Mayo Clinic, Rochester, MN, USA Boston Children’s Hospital, Boston, MA, USA Children’s Center for Digestive Healthcare at Children’s Healthcare of Atlanta, Atlanta, GA, USA University of Southern California, Los Angeles, CA, USA University of Chicago, Chicago, IL, USA Baylor College of Medicine, Houston, TX, USA Cedars Sinai Medical Center, Los Angeles, CA, USA Weill Cornell Medicine, New York, NY, USA Seattle Children’s Hospital at University of Washington, Seattle, WA, USA Medical College of Wisconsin, Milwaukee, WI, USA
Mark Bartlett
Affiliation:
Johns Hopkins Children’s Center, Baltimore, MD, USA Nationwide Children’s Hospital, Columbus, OH, USA Inova Children’s Hospital, Falls Church, VA, USA Primary Children’s Hospital at University of Utah, Salt Lake City, UT, USA MassGeneral Hospital for Children, Boston, MA, USA Children’s Hospital of Philadelphia, Philadelphia, PA, USA Mayo Clinic, Rochester, MN, USA Boston Children’s Hospital, Boston, MA, USA Children’s Center for Digestive Healthcare at Children’s Healthcare of Atlanta, Atlanta, GA, USA University of Southern California, Los Angeles, CA, USA University of Chicago, Chicago, IL, USA Baylor College of Medicine, Houston, TX, USA Cedars Sinai Medical Center, Los Angeles, CA, USA Weill Cornell Medicine, New York, NY, USA Seattle Children’s Hospital at University of Washington, Seattle, WA, USA Medical College of Wisconsin, Milwaukee, WI, USA
Penny Becker
Affiliation:
Johns Hopkins Children’s Center, Baltimore, MD, USA Nationwide Children’s Hospital, Columbus, OH, USA Inova Children’s Hospital, Falls Church, VA, USA Primary Children’s Hospital at University of Utah, Salt Lake City, UT, USA MassGeneral Hospital for Children, Boston, MA, USA Children’s Hospital of Philadelphia, Philadelphia, PA, USA Mayo Clinic, Rochester, MN, USA Boston Children’s Hospital, Boston, MA, USA Children’s Center for Digestive Healthcare at Children’s Healthcare of Atlanta, Atlanta, GA, USA University of Southern California, Los Angeles, CA, USA University of Chicago, Chicago, IL, USA Baylor College of Medicine, Houston, TX, USA Cedars Sinai Medical Center, Los Angeles, CA, USA Weill Cornell Medicine, New York, NY, USA Seattle Children’s Hospital at University of Washington, Seattle, WA, USA Medical College of Wisconsin, Milwaukee, WI, USA
Zev Davidovics
Affiliation:
Johns Hopkins Children’s Center, Baltimore, MD, USA Nationwide Children’s Hospital, Columbus, OH, USA Inova Children’s Hospital, Falls Church, VA, USA Primary Children’s Hospital at University of Utah, Salt Lake City, UT, USA MassGeneral Hospital for Children, Boston, MA, USA Children’s Hospital of Philadelphia, Philadelphia, PA, USA Mayo Clinic, Rochester, MN, USA Boston Children’s Hospital, Boston, MA, USA Children’s Center for Digestive Healthcare at Children’s Healthcare of Atlanta, Atlanta, GA, USA University of Southern California, Los Angeles, CA, USA University of Chicago, Chicago, IL, USA Baylor College of Medicine, Houston, TX, USA Cedars Sinai Medical Center, Los Angeles, CA, USA Weill Cornell Medicine, New York, NY, USA Seattle Children’s Hospital at University of Washington, Seattle, WA, USA Medical College of Wisconsin, Milwaukee, WI, USA
Elizabeth E. Knackstedt
Affiliation:
Johns Hopkins Children’s Center, Baltimore, MD, USA Nationwide Children’s Hospital, Columbus, OH, USA Inova Children’s Hospital, Falls Church, VA, USA Primary Children’s Hospital at University of Utah, Salt Lake City, UT, USA MassGeneral Hospital for Children, Boston, MA, USA Children’s Hospital of Philadelphia, Philadelphia, PA, USA Mayo Clinic, Rochester, MN, USA Boston Children’s Hospital, Boston, MA, USA Children’s Center for Digestive Healthcare at Children’s Healthcare of Atlanta, Atlanta, GA, USA University of Southern California, Los Angeles, CA, USA University of Chicago, Chicago, IL, USA Baylor College of Medicine, Houston, TX, USA Cedars Sinai Medical Center, Los Angeles, CA, USA Weill Cornell Medicine, New York, NY, USA Seattle Children’s Hospital at University of Washington, Seattle, WA, USA Medical College of Wisconsin, Milwaukee, WI, USA
Michael Docktor
Affiliation:
Johns Hopkins Children’s Center, Baltimore, MD, USA Nationwide Children’s Hospital, Columbus, OH, USA Inova Children’s Hospital, Falls Church, VA, USA Primary Children’s Hospital at University of Utah, Salt Lake City, UT, USA MassGeneral Hospital for Children, Boston, MA, USA Children’s Hospital of Philadelphia, Philadelphia, PA, USA Mayo Clinic, Rochester, MN, USA Boston Children’s Hospital, Boston, MA, USA Children’s Center for Digestive Healthcare at Children’s Healthcare of Atlanta, Atlanta, GA, USA University of Southern California, Los Angeles, CA, USA University of Chicago, Chicago, IL, USA Baylor College of Medicine, Houston, TX, USA Cedars Sinai Medical Center, Los Angeles, CA, USA Weill Cornell Medicine, New York, NY, USA Seattle Children’s Hospital at University of Washington, Seattle, WA, USA Medical College of Wisconsin, Milwaukee, WI, USA
Michael Dole
Affiliation:
Johns Hopkins Children’s Center, Baltimore, MD, USA Nationwide Children’s Hospital, Columbus, OH, USA Inova Children’s Hospital, Falls Church, VA, USA Primary Children’s Hospital at University of Utah, Salt Lake City, UT, USA MassGeneral Hospital for Children, Boston, MA, USA Children’s Hospital of Philadelphia, Philadelphia, PA, USA Mayo Clinic, Rochester, MN, USA Boston Children’s Hospital, Boston, MA, USA Children’s Center for Digestive Healthcare at Children’s Healthcare of Atlanta, Atlanta, GA, USA University of Southern California, Los Angeles, CA, USA University of Chicago, Chicago, IL, USA Baylor College of Medicine, Houston, TX, USA Cedars Sinai Medical Center, Los Angeles, CA, USA Weill Cornell Medicine, New York, NY, USA Seattle Children’s Hospital at University of Washington, Seattle, WA, USA Medical College of Wisconsin, Milwaukee, WI, USA
Grace Felix
Affiliation:
Johns Hopkins Children’s Center, Baltimore, MD, USA
Jonathan Gisser
Affiliation:
Nationwide Children’s Hospital, Columbus, OH, USA
Suchitra Hourigan
Affiliation:
Inova Children’s Hospital, Falls Church, VA, USA
Kyle Jensen
Affiliation:
Primary Children’s Hospital at University of Utah, Salt Lake City, UT, USA
Jess Kaplan
Affiliation:
MassGeneral Hospital for Children, Boston, MA, USA
Judith Kelsen
Affiliation:
Children’s Hospital of Philadelphia, Philadelphia, PA, USA
Melissa Kennedy
Affiliation:
Children’s Hospital of Philadelphia, Philadelphia, PA, USA
Sahil Khanna
Affiliation:
Mayo Clinic, Rochester, MN, USA
McKenzie Leier
Affiliation:
Boston Children’s Hospital, Boston, MA, USA
Jeffery Lewis
Affiliation:
Children’s Center for Digestive Healthcare at Children’s Healthcare of Atlanta, Atlanta, GA, USA
Ashley Lodarek
Affiliation:
Boston Children’s Hospital, Boston, MA, USA
Sonia Michail
Affiliation:
University of Southern California, Los Angeles, CA, USA
Paul Mitchell
Affiliation:
Boston Children’s Hospital, Boston, MA, USA
Maria Oliva‐Hemker
Affiliation:
Johns Hopkins Children’s Center, Baltimore, MD, USA
Tiffany Patton
Affiliation:
University of Chicago, Chicago, IL, USA
Karen Queliza
Affiliation:
Baylor College of Medicine, Houston, TX, USA
Namita Singh
Affiliation:
Cedars Sinai Medical Center, Los Angeles, CA, USA
Aliza Solomon
Affiliation:
Weill Cornell Medicine, New York, NY, USA
David Suskind
Affiliation:
Seattle Children’s Hospital at University of Washington, Seattle, WA, USA
Steven Werlin
Affiliation:
Medical College of Wisconsin, Milwaukee, WI, USA
Richard Kellermayer
Affiliation:
Baylor College of Medicine, Houston, TX, USA
Stacy Kahn
Affiliation:
Boston Children’s Hospital, Boston, MA, USA
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Abstract

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OBJECTIVES/SPECIFIC AIMS: Clostridium difficile infection (CDI) is the most common cause of antibiotic-associated diarrhea and an increasingly common infection in children in both hospital and community settings. Between 20% and 30% of pediatric patients will have a recurrence of symptoms in the days to weeks following an initial infection. Multiple recurrences have been successfully treated with fecal microbiota transplantation (FMT), though the body of evidence in pediatric patients is limited primarily to case reports and case series. The goal of our study was to better understand practices, success, and safety of FMT in children as well as identify risk factors associated with a failed FMT in our pediatric patients. METHODS/STUDY POPULATION: This multicenter retrospective analysis included 373 patients who underwent FMT for CDI between January 1, 2006 and January 1, 2017 from 18 pediatric centers. Demographics, baseline characteristics, FMT practices, C. difficile outcomes, and post-FMT complications were collected through chart abstraction. Successful FMT was defined as no recurrence of CDI within 60 days after FMT. Of the 373 patients in the cohort, 342 had known outcome data at two months post-FMT and were included in the primary analysis evaluating risk factors for recurrence post-FMT. An additional six patients who underwent FMT for refractory CDI were excluded from the primary analysis. Unadjusted analysis was performed using Wilcoxon rank-sum test, Pearson χ2 test, or Fisher exact test where appropriate. Stepwise logistic regression was utilized to determine independent predictors of success. RESULTS/ANTICIPATED RESULTS: The median age of included patients was 10 years (IQR; 3.0, 15.0) and 50% of patients were female. The majority of the cohort was White (89.0%). Comorbidities included 120 patients with inflammatory bowel disease (IBD) and 14 patients who had undergone a solid organ or stem cell transplantation. Of the 336 patients with known outcomes at two months, 272 (81%) had a successful outcome. In the 64 (19%) patients that did have a recurrence, 35 underwent repeat FMT which was successful in 20 of the 35 (57%). The overall success rate of FMT in preventing further episodes of CDI in the cohort with known outcome data was 87%. Unadjusted predictors of a primary FMT response are summarized. Based on stepwise logistic regression modeling, the use of fresh stool, FMT delivery via colonoscopy, the lack of a feeding tube, and a lower number of CDI episodes before undergoing FMT were independently associated with a successful outcome. There were 20 adverse events in the cohort assessed to be related to FMT, 6 of which were felt to be severe. There were no deaths assessed to be related to FMT in the cohort. DISCUSSION/SIGNIFICANCE OF IMPACT: The overall success of FMT in pediatric patients with recurrent or severe CDI is 81% after a single FMT. Children without a feeding tube, who receive an early FMT, FMT with fresh stool, or FMT via colonoscopy are less likely to have a recurrence of CDI in the 2 months following FMT. This is the first large study of FMT for CDI in a pediatric cohort. These findings, if confirmed by additional prospective studies, will support alterations in the practice of FMT in children.

Type
Health Equity & Community Engagement
Information
Journal of Clinical and Translational Science , Volume 2 , Supplement S1 , June 2018 , pp. 64
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
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© The Association for Clinical and Translational Science 2018