title: Effectiveness of fecal-derived microbiota transfer using orally administered capsules for recurrent Clostridium difficile infection.
abstract: BACKGROUND
  Clostridium difficile infection (CDI), a complication of antibiotic-induced injury to the gut microbiome, is a prevalent and dangerous cause of infectious diarrhea. Antimicrobial therapy for CDI is typically effective for acute symptoms, but up to one third of patients later experience recurrent CDI. Fecal-derived microbiota transplantation (FMT) can ameliorate the underlying dysbiosis and is highly effective for recurrent CDI. Traditional methods of FMT are limited by patient discomfort, risk and inefficient procedures. Many individuals with recurrent CDI have extensive comorbidities and advanced age. Widespread use of FMT requires strategies that are non-invasive, scalable and applicable across healthcare settings.
  
  
  METHODS
  A method to facilitate microbiota transfer was developed. Fecal samples were collected and screened for potential pathogens. Bacteria were purified, concentrated, cryopreserved and formulated into multi-layered capsules. Capsules were administered to patients with recurrent CDI, who were then monitored for 90 days.
  
  
  RESULTS
  Thirteen women and six men with recurrent CDI were provided with microbiota transfer with orally administered capsules. The procedure was well tolerated. Thirteen individuals responded to a single course. Four patients were cured after a second course. There were 2 failures. The cumulative clinical cure rate of 89% is similar to the rates achieved with reported fecal-derived transplantation procedures.
  
  
  CONCLUSIONS
  Recurrent CDI represents a profound dysbiosis and a debilitating chronic disease. Stable cure can be achieved by restoring the gut microbiome with an effective, well-tolerated oral capsule treatment. This strategy of microbiota transfer can be widely applied and is particularly appropriate for frail patients.
authors.affiliation: The Karin and Dayton Brown, Jr. Division of Infectious Diseases, Department of Medicine, North Shore-Long Island Jewish Health System & Hofstra North Shore-LIJ School of Medicine, 400 Community Drive, 11030, Manhasset, New York, USA. bhirsch@nshs.edu.
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Hirsch
authors.affiliation: The Karin and Dayton Brown, Jr. Division of Infectious Diseases, Department of Medicine, North Shore-Long Island Jewish Health System & Hofstra North Shore-LIJ School of Medicine, 400 Community Drive, 11030, Manhasset, New York, USA. nsaraiya13@nshs.edu.
authors.forename: Nimit
authors.initials: N
authors.lastname: Saraiya
authors.affiliation: The Karin and Dayton Brown, Jr. Division of Infectious Diseases, Department of Medicine, North Shore-Long Island Jewish Health System & Hofstra North Shore-LIJ School of Medicine, 400 Community Drive, 11030, Manhasset, New York, USA. kpoeth@nshs.edu.
authors.forename: Kaitlin
authors.initials: K
authors.lastname: Poeth
authors.affiliation: Department of Population Health, North Shore-Long Island Jewish Health System & Hofstra North Shore-LIJ School of Medicine, Manhasset, New York, USA. rschwartz3@nshs.edu.
authors.forename: Rebecca M
authors.initials: RM
authors.lastname: Schwartz
authors.affiliation: The Karin and Dayton Brown, Jr. Division of Infectious Diseases, Department of Medicine, North Shore-Long Island Jewish Health System & Hofstra North Shore-LIJ School of Medicine, 400 Community Drive, 11030, Manhasset, New York, USA. mepstein@nshs.edu.
authors.forename: Marcia E
authors.initials: ME
authors.lastname: Epstein
authors.affiliation: Symbiotic Health Inc., New York, New York, USA. ghonig@symbioticbio.com.
authors.forename: Gerard
authors.initials: G
authors.lastname: Honig
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002214:Capsules; D016360:Clostridioides difficile / Q000302:isolation & purification / Q000472:pathogenicity; D003015:Clostridium Infections / Q000382:microbiology / Q000473:pathology / Q000517:prevention & control*; D000069467:Fecal Microbiota Transplantation; D005243:Feces / Q000382:microbiology*; D005260:Female; D006801:Humans; D007422:Intestines / Q000382:microbiology*; D008297:Male; D064307:Microbiota; D008875:Middle Aged; D012008:Recurrence; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002214:Capsules