title: Randomised clinical trial: the effectiveness of Lactobacillus reuteri ATCC 55730 rectal enema in children with active distal ulcerative colitis.
abstract: BACKGROUND
  Intestinal microbiota manipulation, one of the pathogenetic components of inflammatory bowel disease (IBD), has become an attractive therapy for ulcerative colitis (UC).
  
  
  OBJECTIVE
  To assess in children with active distal UC the effectiveness of Lactobacillus (L) reuteri ATCC 55730 enema on inflammation and cytokine expression of rectal mucosa.
  
  
  METHODS
  A total of 40 patients (median age: 7.2 years range 6-18) with mild to moderate UC were enrolled in a prospective, randomised, placebo-controlled study. They received an enema solution containing 10(10) CFU of L. reuteri ATCC 55730 or placebo for 8 weeks, in addition to oral mesalazine. Clinical endoscopic and histological scores as well as rectal mucosal expression levels of IL-10, IL-1β, TNFα and IL-8 were evaluated at the beginning and at the end of the trial.
  
  
  RESULTS
  Thirty-one patients accomplished the trial (17 males, median age 13 year, range 7-18). Mayo score (including clinical and endoscopic features) decreased significantly in the L. reuteri group (3.2 ± 1.3 vs. 8.6 ± 0.8, P < 0.01) compared with placebo (7.1 ± 1.1 vs. 8.7 ± 0.7, NS); furthermore, histological score significantly decrease only in the L. reuteri group (0.6 ± 0.5 vs. 4.5 ± 0.6, P < 0.01) (placebo: 2.9 ± 0.8 vs. 4.6 ± 0.6, NS). At the post-trial evaluation of cytokine mucosal expression levels, IL-10 significantly increased (P < 0.01) whereas IL-1β, TNFα and IL-8 significantly decreased (P < 0.01) only in the L. reuteri group.
  
  
  CONCLUSIONS
  In children with active distal ulcerative colitis, rectal infusion of L. reuteri is effective in improving mucosal inflammation and changing mucosal expression levels of some cytokines involved in the mechanisms of inflammatory bowel disease.
authors.affiliation: Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Oliva
authors.forename: G
authors.initials: G
authors.lastname: Di Nardo
authors.forename: F
authors.initials: F
authors.lastname: Ferrari
authors.forename: S
authors.initials: S
authors.lastname: Mallardo
authors.forename: P
authors.initials: P
authors.lastname: Rossi
authors.forename: G
authors.initials: G
authors.lastname: Patrizi
authors.forename: S
authors.initials: S
authors.lastname: Cucchiara
authors.forename: L
authors.initials: L
authors.lastname: Stronati
mesh_terms: D000285:Administration, Rectal; D000293:Adolescent; D002648:Child; D003093:Colitis, Ulcerative / Q000628:therapy*; D016207:Cytokines / Q000378:metabolism; D004311:Double-Blind Method; D004733:Enema / Q000379:methods*; D005260:Female; D006801:Humans; D007413:Intestinal Mucosa / Q000378:metabolism; D052200:Limosilactobacillus reuteri; D008297:Male; D019936:Probiotics / Q000008:administration & dosage*; D013223:Statistics as Topic; D016896:Treatment Outcome
chemical_list: D016207:Cytokines