A Randomized, Double-blind Trial of Lactobacillus GG Versus Placebo in Addition to Standard Maintenance Therapy for Children with Crohnʼs Disease
Year: 2005
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Source: Inflammatory Bowel Diseases
Institutions: Boston Children's Hospital, Harvard University, Comer Children's Hospital, Children's Hospital of Philadelphia, Tufts Medical Center, Nemours Children’s Clinic, Nemours Children's Clinic, Nemours Children's Clinic, Texas Children's Hospital, Tufts University, Medical College of Wisconsin, Columbia University Irving Medical Center, Seattle Children's Hospital, Johns Hopkins University, Johns Hopkins Medicine, Johns Hopkins Hospital, Morristown Medical Center, Children's Hospital of Michigan, Children's Hospital & Medical Center, University of Nebraska Medical Center
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Genetics
Domain: Life Sciences
Open Access status: bronze
Award: G1049408530
OpenAlex ID: W2012166553