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The probiotic VSL#3 has anti-inflammatory effects and could reduce endoscopic recurrence after surgery for Crohn's
Richard N Fedorak1, Brian G Feagan2, Naomi Hotte1
1Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada.
Background & Aims:
Probiotic formulations of single species of bacteria have not been effective in preventing the recurrence of Crohn's disease after surgery. We investigated the ability of VSL#3, a mixture of 8 different bacterial probiotic species, to prevent Crohn's disease recurrence after surgery in a multicenter, randomized, double-blind, placebo-controlled trial.
Methods:
Within 30 days of ileocolonic resection and re-anastomosis, patients with Crohn's disease were randomly assigned to groups given 1 sachet of VSL#3 (900 billion viable bacteria, comprising 4 strains of Lactobacillus, 3 strains of Bifidobacterium, and 1 strain of Streptococcus salivarius subspecies thermophilus) (n = 59) or matching placebo (n = 60). Colonoscopy was performed at days 90 and 365 to evaluate the neoterminal ileum for disease recurrence and obtain mucosal biopsies for cytokine analysis. Patients from both groups with either no or mild endoscopic recurrence at day 90 received VSL#3 until day 365. The primary outcome was the proportion of patients with severe endoscopic recurrence at day 90.
Results:
At day 90, the proportion of patients with severe endoscopic lesions did not differ significantly between VSL#3 (9.3%) and placebo (15.7%, P = .19). The proportions of patients with non-severe lesions at day 90 who had severe endoscopic recurrence at day 365 were 10.0% in the early VSL#3 group (given VSL#3 for the entire 365 days) and 26.7% in the late VSL#3 group (given VSL#3 from days 90 through 365) (P = .09). Aggregate rates of severe recurrence (on days 90 and 365) were not statistically different, 20.5% of subjects in the early VSL#3 group and 42.1% in the late VSL#3 group. Patients receiving VSL#3 had reduced mucosal inflammatory cytokine levels compared with placebo at day 90 (P < .05). Crohn's disease activity index and inflammatory bowel disease quality of life scores were similar in the 2 groups.
Conclusions:
There were no statistical differences in endoscopic recurrence rates at day 90 between patients who received VSL#3 and patients who received placebo. Lower mucosal levels of inflammatory cytokines and a lower rate of recurrence among patients who received early VSL#3 (for the entire 365 days) indicate that this probiotic should be further investigated for prevention of Crohn's disease recurrence. Clinical trials.gov number: NCT00175292.
Insights
This study found that the probiotic VSL#3 did not significantly prevent Crohn's disease recurrence after surgery at 90 days. However, early VSL#3 administration showed potential for reducing recurrence and inflammation.
Area of Science:
- Gastroenterology
- Microbiology
- Immunology
Background:
- Single-species probiotics have failed to prevent Crohn's disease recurrence post-surgery.
- Investigating a multi-species probiotic (VSL#3) for preventing Crohn's disease recurrence.
Purpose of the Study:
- To evaluate the efficacy of VSL#3 in preventing endoscopic recurrence of Crohn's disease after ileocolonic resection.
- To assess the impact of VSL#3 on mucosal cytokine levels and disease activity.
Main Methods:
- Multicenter, randomized, double-blind, placebo-controlled trial.
- Patients received VSL#3 (900 billion bacteria) or placebo within 30 days of surgery.
- Colonoscopy and biopsies were performed at 90 and 365 days to assess recurrence and cytokine levels.
Main Results:
- No significant difference in severe endoscopic recurrence at day 90 between VSL#3 and placebo groups (9.3% vs 15.7%).
- Early VSL#3 administration (365 days) showed a trend towards lower recurrence rates at day 365 (10.0% vs 26.7%).
- VSL#3 reduced mucosal inflammatory cytokine levels at day 90 compared to placebo.
Conclusions:
- VSL#3 did not significantly prevent Crohn's disease recurrence at 90 days post-surgery.
- Early VSL#3 administration warrants further investigation for Crohn's disease recurrence prevention.
- Reduced inflammatory markers suggest a potential immunomodulatory role for VSL#3.
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