The Probiotic VSL#3 Has Anti-inflammatory Effects and Could Reduce Endoscopic Recurrence After Surgery for XXXX .

@entity1 @entity75 @entity254 @entity29 @entity5858 @entity30
BACKGROUND _ AIMS: Probiotic formulations of single species of bacteria have not been effective in preventing the recurrence of @entity30 after surgery. We investigated the ability of VSL#3, a mixture of 8 different bacterial probiotic species, to prevent @entity30 recurrence after surgery in a multicenter, randomized, double-blind, placebo-controlled trial. METHODS: Within 30 days of ileocolonic resection and re- @entity254 , @entity1 with @entity30 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 @entity5858 ) (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. @entity1 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 @entity1 with severe endoscopic recurrence at day  90. RESULTS: At day 90, the proportion of @entity1 with severe @entity75 did not differ significantly between VSL#3 (9.3%) and placebo (15.7%, P  = .19). The proportions of @entity1 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. @entity1 receiving VSL#3 had reduced mucosal inflammatory cytokine levels compared with placebo at day 90 (P < .05). @entity30 activity index and @entity29 quality of life scores were similar in the 2 groups. CONCLUSIONS: There were no statistical differences in endoscopic recurrence rates at day 90 between @entity1 who received VSL#3 and @entity1 who received placebo. Lower mucosal levels of inflammatory cytokines and a lower rate of recurrence among @entity1 who received early VSL#3 (for the entire 365 days) indicate that this probiotic should be further investigated for prevention of @entity30 recurrence. Clinical trials.gov number: NCT00175292.
