title: Safety, tolerability, and clinical response after fecal transplantation in children and young adults with ulcerative colitis.
abstract: OBJECTIVE
  Colonic dysbiosis contributes to the development of colonic inflammation in ulcerative colitis (UC). Fecal microbial transplantation (FMT) is being proposed as a novel treatment for UC because it can eliminate dysbiosis; however, no prospective data exist. We initiated a pilot study to evaluate feasibility and safety of FMT in children with UC.
  
  
  METHODS
  Ten children, 7 to 21 years of age, with mild-to-moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) received freshly prepared fecal enemas daily for 5 days. Data on tolerability, adverse events, and disease activity were collected during FMT and weekly for 4 weeks after FMT. Clinical response was defined as decrease in PUCAI by >15, and decrease in PUCAI to <10 was considered clinical remission.
  
  
  RESULTS
  No serious adverse events were noted. Mild (cramping, fullness, flatulence, bloating, diarrhea, and blood in stool) to moderate (fever) adverse events were self-limiting. One subject could not retain fecal enemas. Average tolerated enema volume by remaining 9 subjects was 165 mL/day. After FMT, 7 of the 9 (78%) subjects showed clinical response within 1 week, 6 of the 9 (67%) subjects maintained clinical response at 1 month, and 3 of the 9 (33%) subjects achieved clinical remission at 1 week after FMT. Median PUCAI significantly improved after FMT (P = 0.03) compared with the baseline.
  
  
  CONCLUSIONS
  Fecal enemas were feasible and tolerated by children with UC. Adverse events were acceptable, self-limiting, and manageable by subjects. FMT indicated efficacy in the treatment of UC.
authors.affiliation: Spectrum Health, Helen DeVos Children's Hospital, Grand Rapids, MI, USA. Sachin.Kunde@helendevoschildrens.org
authors.forename: Sachin
authors.initials: S
authors.lastname: Kunde
authors.forename: Angela
authors.initials: A
authors.lastname: Pham
authors.forename: Sarah
authors.initials: S
authors.lastname: Bonczyk
authors.forename: Teri
authors.initials: T
authors.lastname: Crumb
authors.forename: Meg
authors.initials: M
authors.lastname: Duba
authors.forename: Harold
authors.initials: H
authors.lastname: Conrad
authors.forename: Deborah
authors.initials: D
authors.lastname: Cloney
authors.forename: Subra
authors.initials: S
authors.lastname: Kugathasan
mesh_terms: D000285:Administration, Rectal; D000293:Adolescent; D000328:Adult; D001691:Biological Therapy / Q000009:adverse effects; D002648:Child; D003093:Colitis, Ulcerative / Q000382:microbiology / Q000503:physiopathology / Q000628:therapy*; D046148:Donor Selection; D064806:Dysbiosis / Q000209:etiology / Q000517:prevention & control*; D005190:Family; D005240:Feasibility Studies; D005243:Feces / Q000382:microbiology*; D005260:Female; D005500:Follow-Up Studies; D006776:Hospitals, Pediatric; D006801:Humans; D008297:Male; D008824:Michigan; D010044:Outpatient Clinics, Hospital; D010865:Pilot Projects; D012074:Remission Induction; D012720:Severity of Illness Index; D035703:Therapies, Investigational / Q000009:adverse effects; D055815:Young Adult