title: Fecal microbial transplant via nasogastric tube for active pediatric ulcerative colitis.
abstract: BACKGROUND
  Ulcerative colitis (UC), a chronic inflammatory disease of the large intestine, is characterized by a dysregulated immune reaction. UC is associated with fecal dysbiosis. Human and animal studies support the fact that the gastrointestinal microbiome may trigger the intestinal immune response, resulting in UC. Fecal microbial transplantation (FMT), by changing the gastrointestinal microbiome of patients with UC, may be a therapeutic option.
  
  
  METHODS
  Four patients with moderate symptoms defined by the Pediatric Ulcerative Colitis Activity Index were enrolled in a prospective, open-label study of FMT via nasogastric tube in pediatric UC (US Food and Drug Administration IND 14942). After the donor and patient evaluation, patients received FMT with follow-up evaluations at 2, 6, and 12 weeks after transplantation. Study subjects were maintained on their pretransplant medications. The Pediatric Ulcerative Colitis Activity Index score, C-reactive protein, and stool calprotectin were completed during each study visit.
  
  
  RESULTS
  Four patients with UC were enrolled (all boys). Ages ranged from 13 to 16 years. Patients tolerated FMT without adverse effects. None of the patients clinically improved with FMT, nor were there any significant changes in stool calprotectin or laboratory values, including C-reactive protein, albumin, and hematocrit. Three individuals received additional standard medical therapies before the end of the study.
  
  
  CONCLUSIONS
  This study, although showing that single-dose FMT via nasogastric tube is well tolerated in active pediatric UC, did not show any clinical or laboratory benefit.
authors.affiliation: *Department of Pediatrics, Division of Gastroenterology, Seattle Children's Hospital and University of Washington, Seattle †Department of Pediatrics, Division of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, CA.
authors.forename: David L
authors.initials: DL
authors.lastname: Suskind
authors.forename: Namita
authors.initials: N
authors.lastname: Singh
authors.forename: Heather
authors.initials: H
authors.lastname: Nielson
authors.forename: Ghassan
authors.initials: G
authors.lastname: Wahbeh
mesh_terms: D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D003093:Colitis, Ulcerative / Q000188:drug therapy / Q000382:microbiology / Q000503:physiopathology / Q000628:therapy*; D003131:Combined Modality Therapy / Q000009:adverse effects; D046148:Donor Selection; D005243:Feces / Q000382:microbiology; D005500:Follow-Up Studies; D006776:Hospitals, Pediatric; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007441:Intubation, Gastrointestinal; D008297:Male; D064307:Microbiota; D010044:Outpatient Clinics, Hospital; D019936:Probiotics / Q000627:therapeutic use; D012720:Severity of Illness Index; D035703:Therapies, Investigational / Q000009:adverse effects; D014861:Washington
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D007166:Immunosuppressive Agents