title: Fecal microbial transplant effect on clinical outcomes and fecal microbiome in active Crohn's disease.
abstract: BACKGROUND
  Crohn's disease (CD) is a chronic idiopathic inflammatory intestinal disorder associated with fecal dysbiosis. Fecal microbial transplant (FMT) is a potential therapeutic option for individuals with CD based on the hypothesis that changing the fecal dysbiosis could promote less intestinal inflammation.
  
  
  METHODS
  Nine patients, aged 12 to 19 years, with mild-to-moderate symptoms defined by Pediatric Crohn's Disease Activity Index (PCDAI of 10-29) were enrolled into a prospective open-label study of FMT in CD (FDA IND 14942). Patients received FMT by nasogastric tube with follow-up evaluations at 2, 6, and 12 weeks. PCDAI, C-reactive protein, and fecal calprotectin were evaluated at each study visit.
  
  
  RESULTS
  All reported adverse events were graded as mild except for 1 individual who reported moderate abdominal pain after FMT. All adverse events were self-limiting. Metagenomic evaluation of stool microbiome indicated evidence of FMT engraftment in 7 of 9 patients. The mean PCDAI score improved with patients having a baseline of 19.7 ± 7.2, with improvement at 2 weeks to 6.4 ± 6.6 and at 6 weeks to 8.6 ± 4.9. Based on PCDAI, 7 of 9 patients were in remission at 2 weeks and 5 of 9 patients who did not receive additional medical therapy were in remission at 6 and 12 weeks. No or modest improvement was seen in patients who did not engraft or whose microbiome was most similar to their donor.
  
  
  CONCLUSIONS
  This is the first study to demonstrate that FMT for CD may be a possible therapeutic option for CD. Further prospective studies are required to fully assess the safety and efficacy of the FMT in patients with CD.
authors: *Department of Pediatrics, Division of Gastroenterology, Seattle Children's Hospital, University of Washington, Seattle, Washington; Departments of †Microbiology, and ‡Laboratory Medicine, University of Washington, Seattle, Washington; §Department of Pediatrics, Division of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, California; and Departments of ‖Medicine, ¶Immunology, and **Genome Sciences, University of Washington, Seattle, Washington.
authors: David L
authors: DL
authors: Suskind
authors: Mitchell J
authors: MJ
authors: Brittnacher
authors: Ghassan
authors: G
authors: Wahbeh
authors: Michele L
authors: ML
authors: Shaffer
authors: Hillary S
authors: HS
authors: Hayden
authors: Xuan
authors: X
authors: Qin
authors: Namita
authors: N
authors: Singh
authors: Christopher J
authors: CJ
authors: Damman
authors: Kyle R
authors: KR
authors: Hager
authors: Heather
authors: H
authors: Nielson
authors: Samuel I
authors: SI
authors: Miller
mesh_terms: D000293:Adolescent; D000328:Adult; D001691:Biological Therapy; D002648:Child; D019295:Computational Biology; D003424:Crohn Disease / Q000382:microbiology / Q000503:physiopathology / Q000628:therapy*; D005243:Feces / Q000382:microbiology*; D005260:Female; D006801:Humans; D008297:Male; D054892:Metagenome; D064307:Microbiota; D011379:Prognosis; D055815:Young Adult
references: Scand J Gastroenterol. 2002 Sep;37(9):1034-41
references: 12374228
references: J Clin Microbiol. 2014 Feb;52(2):398-406
references: 24478468
references: Gastroenterology. 2004 May;126(6):1620-33
references: 15168372
references: Med J Aust. 1989 May 15;150(10):604
references: 2783214
references: Dis Colon Rectum. 1993 Aug;36(8):757-62
references: 8348866
references: Surgery. 1958 Nov;44(5):854-9
references: 13592638
references: Am J Gastroenterol. 2004 Nov;99(11):2235-41
references: 15555007
references: J Pediatr Gastroenterol Nutr. 2005 Oct;41(4):416-21
references: 16205508
references: Proc Natl Acad Sci U S A. 2007 Aug 21;104(34):13780-5
references: 17699621
references: J Clin Gastroenterol. 2010 Sep;44(8):551-61
references: 20716985
references: Clin Gastroenterol Hepatol. 2011 Dec;9(12):1044-9
references: 21871249
references: Am J Gastroenterol. 2011 Dec;106(12):2133-42
references: 21912437
references: Am J Epidemiol. 2012 Apr 15;175(8):775-84
references: 22366379
references: Nat Methods. 2012 Aug;9(8):811-4
references: 22688413
references: Pediatrics. 2012 Oct;130(4):e794-803
references: 23008454
references: BMC Bioinformatics. 2012;13 Suppl 19:S10
references: 23282463
references: J Gastroenterol Hepatol. 2013 Apr;28(4):613-9
references: 23216550