A Randomized, Double-blind Trial of Lactobacillus GG Versus Placebo in Addition to Standard Maintenance Therapy for Children with Crohnʼs 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.

Soluble Proteins Produced by Probiotic Bacteria Regulate Intestinal Epithelial Cell Survival and Growth

“…32 These results emphasize a current problem regarding the use of probiotic therapy, namely the difficulty determining the bioavailability of bacteria in the gastrointestinal tract. In addition, use of live probiotic bacteria raises concerns because of several cases of bacteremia associated with probiotic therapy in very young 33 and immunocompromised patients.…”

Randomised clinical trial: the effectiveness of Lactobacillus reuteri ATCC 55730 rectal enema in children with active distal ulcerative colitis

“…Thirty-one patients accomplished the trial (17 males, median age 13 year, range [7][8][9][10][11][12][13][14][15][16][17][18]. Mayo score (including clinical and endoscopic features) decreased significantly in the L. reuteri group (3.2 AE 1.3 vs. 8.6 AE 0.8, P < 0.01) compared with placebo (7.1 AE 1.1 vs. 8.7 AE 0.7, NS); furthermore, histological score significantly decrease only in the L. reuteri group (0.6 AE 0.5 vs. 4.5 AE 0.6, P < 0.01) (placebo: 2.9 AE 0.8 vs. 4.6 AE 0.6, NS).…”

“…39 However, the studies on the use of probiotics in IBD are heterogeneous for the microorganism species or strains given as well as for methodology and patient populations. 15,16 It should be also considered that benefits described with one species are not necessarily attributed to others. On the other hand, probiotics used in complex disorders such as IBD, with the aim to modulate the complex interactions between intestinal mucosa and gut microbiota, should possess some critical properties, such as the ability to adhere to the intestinal mucosa and to interact with immunological cells harbouring the gut wall.…”

Probiotics for Autoimmune Diseases: Is There a Benefit?

“…Another randomized, double blind study compared LGG vs. placebo in addition to standard maintenance therapy in a group of 75 children. These studies did not find any advantage for LGG compared with placebo in maintaining medically-induced remission [84].…”

“…Three studies using LGG have not confirmed the effectiveness of this probiotic as a maintenance strategy after surgically-induced remission [84,85]. Another clinical trial utilizing treatment with LGG after surgical resection failed to show prevention of early endoscopic recurrence when compared to placebo.…”