title: A randomized, double-blind trial of Lactobacillus GG versus placebo in addition to standard maintenance therapy for children with Crohn's disease.
abstract: Probiotics are widely used by patients with Crohn's disease (CD) in an attempt to improve their health, but few controlled studies have been done to evaluate the efficacy of these therapies. We conducted a randomized, placebo-controlled trial of the probiotic Lactobacillus rhamnosus strain GG (LGG) to see if the addition of LGG to standard therapy prolonged remission in children with CD. Concomitant medications allowed in the study included aminosalicylates, 6-mercaptopurine, azathioprine, and low-dose alternate day corticosteroids. Seventy-five children (age range, 5-21 yr) with CD in remission were randomized to either LGG (n=39) or placebo (n=36) and followed for up to 2 years. The median time to relapse was 9.8 months in the LGG group and 11.0 months in the placebo group (P=0.24); 31% (12/39) of patients in the LGG group developed a relapse compared with 6/36 (17%) of the placebo group (P=0.18). The LGG was well tolerated, with a side effect profile comparable with placebo. This study suggests that LGG does not prolong time to relapse in children with CD when given as an adjunct to standard therapy.
authors.affiliation: Division of Pediatric Gastroenterology, Children's Hospital, Boston, Massachusetts 02115, USA. Athos.Bousvaros@childrens.harvard.edu
authors.forename: Athos
authors.initials: A
authors.lastname: Bousvaros
authors.forename: Stefano
authors.initials: S
authors.lastname: Guandalini
authors.forename: Robert N
authors.initials: RN
authors.lastname: Baldassano
authors.forename: Christine
authors.initials: C
authors.lastname: Botelho
authors.forename: Jonathan
authors.initials: J
authors.lastname: Evans
authors.forename: George D
authors.initials: GD
authors.lastname: Ferry
authors.forename: Barry
authors.initials: B
authors.lastname: Goldin
authors.forename: Lori
authors.initials: L
authors.lastname: Hartigan
authors.forename: Subra
authors.initials: S
authors.lastname: Kugathasan
authors.forename: Joseph
authors.initials: J
authors.lastname: Levy
authors.forename: Karen F
authors.initials: KF
authors.lastname: Murray
authors.forename: Maria
authors.initials: M
authors.lastname: Oliva-Hemker
authors.forename: Joel R
authors.initials: JR
authors.lastname: Rosh
authors.forename: Vasundhara
authors.initials: V
authors.lastname: Tolia
authors.forename: Anna
authors.initials: A
authors.lastname: Zholudev
authors.forename: Jon A
authors.initials: JA
authors.lastname: Vanderhoof
authors.forename: Patricia L
authors.initials: PL
authors.lastname: Hibberd
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D003424:Crohn Disease / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007778:Lactobacillus; D008297:Male; D010919:Placebos; D019936:Probiotics / Q000627:therapeutic use*; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010919:Placebos