The probiotic VSL#3 has anti-inflammatory effects and could reduce endoscopic recurrence after surgery for Crohn's disease.
Level 2 - randomized trial
Individual multicenter randomized controlled trial
PubMed 25460016 · doi:10.1016/j.cgh.2014.10.031
What was done
Patients with Crohn's disease who underwent ileocolonic resection and re-anastomosis within the prior 30 days were randomized in a multicenter, double-blind, placebo-controlled trial to receive one daily sachet of VSL#3 containing 900 billion viable bacteria (n = 59) or matching placebo (n = 60). Colonoscopy and mucosal biopsies for cytokine analysis were performed at days 90 and 365. Patients with no or mild endoscopic recurrence at day 90 received VSL#3 through day 365. The primary outcome was the proportion of patients with severe endoscopic recurrence at day 90.
What was found
At day 90, severe endoscopic recurrence occurred in 9.3% of the VSL#3 group compared with 15.7% of the placebo group (P = .19). Among patients with non-severe lesions at day 90, severe recurrence at day 365 was 10.0% in early VSL#3 recipients (treated for 365 days) versus 26.7% in late VSL#3 recipients (treated from day 90 to 365, P = .09). Aggregate rates of severe recurrence were 20.5% in the early group and 42.1% in the late group without statistical difference. VSL#3 significantly lowered mucosal inflammatory cytokine levels at day 90 (P < .05), while Crohn's disease activity index and quality-of-life scores were similar between groups.
Why it matters
This trial shows that multispecies probiotic therapy induces local mucosal anti-inflammatory effects but does not achieve a statistically significant reduction in severe endoscopic recurrence 90 days after Crohn's disease surgery.
Limits
The sample size of 119 participants may have been underpowered to detect modest differences in endoscopic outcomes. Crossover of non-severe placebo patients to VSL#3 at day 90 precluded a clean full-year placebo comparison, and biological cytokine changes did not translate into clinical disease activity improvements.
Cited by
- contradicts VSL#3 probiotic sachets contain 450 billion bacteria, consisting of Lactobacillus, Bifidobacteria, and other species, and have demonstrated efficacy in human clinical trials for IBS and Crohn's disease.