title: Probiotic preparation VSL#3 induces remission in children with mild to moderate acute ulcerative colitis: a pilot study.
abstract: BACKGROUND
  Ulcerative colitis (UC) is a form of inflammatory bowel disease (IBD) that has periods of exacerbated symptoms and periods that are symptom-free. The treatment of active UC with probiotic bacteria could possibly induce remission. We evaluated the clinical efficacy and safety profile of probiotic preparation VSL#3 in the treatment of mild to moderate acute UC in the pediatric population.
  
  
  METHODS
  Eighteen eligible patients between the ages of 3-17 with mild to moderate acute UC received open-label VSL#3 daily in 2 divided doses for 8 weeks. The disease activity pre- and post-VSL#3 therapy was assessed by the simple clinical colitis activity index (SCCAI); Mayo ulcerative colitis endoscopic score; inflammatory markers: erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP); serum cytokine profiling; and rectal tissue microbial profiling done at baseline and at week 8.
  
  
  RESULTS
  Thirteen patients completed 8 weeks of VSL#3 treatment and 5 patients were withdrawn due to lack of improvement. Remission (defined as SCCAI <or=3) was achieved in 56% of children (n = 10); response (decrease in SCCAI >or=2, but final score <or=5) in 6% (n = 1); and no change or worsening in 39% (n = 7). Post-VSL#3 treatments demonstrated a bacterial taxonomy change in rectal biopsy. The VSL#3 was well tolerated in clinical trials and no biochemical and clinical adverse effects attributed to VSL#3 were identified.
  
  
  CONCLUSIONS
  Treatment of pediatric patients diagnosed with mild to moderate UC with VSL#3 resulted in a remission rate of 56% and a combined remission/response rate of 61%.
authors.affiliation: Division of Pediatric Gastroenterology and Nutrition, Department of Pediatrics, University of Alberta, Stollery Children's Hospital, Edmonton, Alberta, Canada. Hien.Huynh@ualberta.ca
authors.forename: Hien Q
authors.initials: HQ
authors.lastname: Huynh
authors.forename: Jennifer
authors.initials: J
authors.lastname: deBruyn
authors.forename: Leluo
authors.initials: L
authors.lastname: Guan
authors.forename: Hugo
authors.initials: H
authors.lastname: Diaz
authors.forename: Meiju
authors.initials: M
authors.lastname: Li
authors.forename: Safwat
authors.initials: S
authors.lastname: Girgis
authors.forename: Justine
authors.initials: J
authors.lastname: Turner
authors.forename: Richard
authors.initials: R
authors.lastname: Fedorak
authors.forename: Karen
authors.initials: K
authors.lastname: Madsen
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003093:Colitis, Ulcerative / Q000473:pathology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D010865:Pilot Projects; D019936:Probiotics / Q000627:therapeutic use*; D012074:Remission Induction; D012449:Safety; D016896:Treatment Outcome