VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study.
Level 2 - randomized trial
Individual randomized, double-blind, placebo-controlled crossover trial
PubMed 20453678 · doi:10.1097/MPG.0b013e3181ca4d95
What was done
Children and adolescents aged 4 to 18 years meeting eligibility criteria for irritable bowel syndrome (IBS) were enrolled in a multicenter, randomized, double-blind, placebo-controlled crossover trial across 7 pediatric gastroenterology divisions. Following a 2-week baseline assessment via questionnaire, participants were randomized to receive either the probiotic formulation VSL#3 or a placebo for 6 weeks, evaluated every 2 weeks. After a 2-week washout period, participants crossed over to the alternative treatment for an additional 6 weeks.
What was found
A total of 59 children completed the study. VSL#3 was significantly superior to placebo for the primary endpoint of subjective symptom relief (P < 0.05). VSL#3 was also superior in three secondary endpoints: abdominal pain/discomfort (P < 0.05), abdominal bloating/gassiness (P < 0.05), and family assessment of life disruption (P < 0.01). No significant difference was detected in stool pattern (P = 0.06). Placebo response was observed in some parameters in up to 50% of patients. No adverse effects were recorded. Absolute numerical scores and effect sizes were not reported in the abstract.
Why it matters
This study provides evidence that VSL#3 safely improves key clinical symptoms and reduces life disruption in pediatric patients with IBS.
Limits
The abstract reports on 59 completers without specifying the initial number enrolled or dropout rate. Absolute numerical values, baseline severity, and confidence intervals are omitted. The 2-week washout period may be insufficient to prevent probiotic carryover effects, and stool patterns did not significantly improve.
Cited by
- supports Clinical and animal studies have reported therapeutic benefits of high-dose probiotic formulations (such as VSL#3 or Visbiome at 400 to 800 billion CFUs) for colitis and irritable bowel syndrome.