P Gupta1, H Andrew, B S Kirschner, S Guandalini. 1. Section of Pediatric Gastroenterology, Hepatology and Nutrition, The University of Chicago Children's Hospital, Illinois 60637, USA.
Abstract
BACKGROUND:Lactobacillus GG is a safe probiotic bacterium known to transiently colonize the human intestine. It has been found to be useful in treatment of several gastrointestinal conditions characterized by increased gut permeability. In the current study, the efficacy of Lactobacillus GG was investigated in children with Crohn's disease. METHODS: In this open-label pilot evaluation viewed as a necessary preliminary step for a possible subsequent randomized placebo-controlled trial, four children with mildly to moderately active Crohn's disease were givenLactobacillus GG (10(10) colony-forming units [CFU]) in enterocoated tablets twice a day for 6 months. Changes in intestinal permeability were measured by a double sugar permeability test. Clinical activity was determined by measuring the pediatric Crohn's disease activity index. RESULTS: There was a significant improvement in clinical activity 1 week after starting Lactobacillus GG, which was sustained throughout the study period. Median pediatric Crohn's disease activity index scores at 4 weeks were 73% lower than baseline. Intestinal permeability improved in an almost parallel fashion. CONCLUSIONS: Findings in this pilot study show that Lactobacillus GG may improve gut barrier function and clinical status in children with mildly to moderately active, stable Crohn's disease. Randomized, double-blind, placebo-controlled trials are warranted for a final assessment of the efficacy of Lactobacillus GG in Crohn's disease.
RCT Entities:
BACKGROUND: Lactobacillus GG is a safe probiotic bacterium known to transiently colonize the human intestine. It has been found to be useful in treatment of several gastrointestinal conditions characterized by increased gut permeability. In the current study, the efficacy of Lactobacillus GG was investigated in children with Crohn's disease. METHODS: In this open-label pilot evaluation viewed as a necessary preliminary step for a possible subsequent randomized placebo-controlled trial, four children with mildly to moderately active Crohn's disease were given Lactobacillus GG (10(10) colony-forming units [CFU]) in enterocoated tablets twice a day for 6 months. Changes in intestinal permeability were measured by a double sugar permeability test. Clinical activity was determined by measuring the pediatric Crohn's disease activity index. RESULTS: There was a significant improvement in clinical activity 1 week after starting Lactobacillus GG, which was sustained throughout the study period. Median pediatric Crohn's disease activity index scores at 4 weeks were 73% lower than baseline. Intestinal permeability improved in an almost parallel fashion. CONCLUSIONS: Findings in this pilot study show that Lactobacillus GG may improve gut barrier function and clinical status in children with mildly to moderately active, stable Crohn's disease. Randomized, double-blind, placebo-controlled trials are warranted for a final assessment of the efficacy of Lactobacillus GG in Crohn's disease.
Authors: William S Mow; Carol J Landers; A Hillary Steinhart; Brian G Feagan; Ken Croitoru; Ernest Seidman; Gordon R Greenberg; Stephan R Targan Journal: Dig Dis Sci Date: 2004-08 Impact factor: 3.199