Reference
Miele E, Pascarella F, Giannetti E, et al. Effect of a probiotic preparation (VSL#3) on induction and maintenance of remission in children with ulcerative colitis. Am J Gastroenterol 2009;104(2):437-443.
Design
Randomized double-blind intervention trial
Participants
Twenty-nine children between the ages of 1 and 16 years newly diagnosed with ulcerative colitis (UC)
Study Medication and Dosage
A probiotic preparation (“VSL#3”) was administered using a weight-based dosage ranging from 450 billion (for those aged 4 to 6 y) to 1.4 trillion bacteria per day (for those aged 15 to 16 y) or placebo for 1 year. All participants also received steroid induction and mesalamine maintenance treatment.
Outcome Measures
Lichtiger Colitis Activity Index (LCAI) and physicians’ global assessments were used to measure disease activity.
Key Findings
On the basis of LCAI scores, 93% of those assigned to probiotics went into remission, compared with 36% of those given placebo (P<.001). During the year-long trial, relapses occurred in only 21% of those treated with probiotics, but in 73% of those treated with placebo (P=.01). At both 6 and 12 months, endoscopic scores had fallen by more than two-thirds in the probiotics group, compared with nonsignificant declines in the placebo group (P=.05). Changes in histological scores were less impressive (exact data not shown) but still achieved statistical significance compared with findings in the placebo group.
Practice Implications
The probiotic combination used in the current trial is not defined except as a combination of 8 different strains. We may assume that at least some of these 8 strains are likely to be probiotic bacteria with which we are already familiar (eg, Lactobacillus acidophilus, Bacillus brevis, L rhamnosus). Previous trials using the same “VSL#3” have reported efficacy in preventing pouchitis and in increasing remission rates in inflammatory bowel disease.1 As is usually the case with probiotic trials, we are left wondering to what extent the use of different strains might affect the level of efficacy. Hunting for the answer to that question is made more difficult by the complex combination of strains used in the current trial, though earlier preliminary reports using “VSL#3” have been particularly consistent. Nonetheless, a wide variety of probiotics have been reported to have at least related effects on gastrointestinal function.
Regarding the current trial, we are also left to ponder the remarkably high dosage used. Previous efforts using a more typical dose (18 billion/d of L GG strain given to adults) produced results equal to conventional treatment with mesalazinei, but those findings do not tell us whether there is an advantage in going dramatically higher in the dosage.
