Four-strain probiotic exerts a positive effect on irritable bowel syndrome symptoms occurring in inflammatory bowel diseases in absence of inflammation (train-IBD trial).

BACKGROUND: Irritable bowel syndrome (IBS) symptoms are common in patients with inflammatory bowel disease (IBD), with systematic review reporting an overall pooled prevalence of 35-39% in patients with clinical remission. This subset of patients reports a reduced quality of life and increased anxiety and depression. A multi-strain probiotic (Symprove™, Symprove Ltd, Farnham, United Kingdom) has been shown to improve overall symptom severity in patients with IBS and is associated with decreased intestinal inflammation in patients with ulcerative colitis (UC), but not in Crohn's disease (CD). AIM: To ascertain whether this multi-strain probiotic would be effective in an IBS/IBD overlap population. METHODS: The treatment of symptoms in the absence of inflammation in inflammatory bowel diseases trial was a randomized, double-blind, placebo-controlled trial of a four-strain probiotic Symprove, containing Lactobacillus rhamnosus NCIMB 30174, Lactobacillus plantarum NCIMB 30173, Lactobacillus acidophilus NCIMB 30175 and Enterococcus faecium NCIMB 30176. The duration of the study was 3 months, at the end of which IBS-Symptom Severity Score (IBS-SSS) was repeated. Primary Endpoint was a 100-point reduction in IBS-SSS. RESULTS: 61 participants were randomized into the intention-to-treat analysis. 45% of patients receiving the active agent achieved the endpoint compared to 33% of those receiving placebo (P = 0.42). In UC, 50% of patients receiving placebo achieved the endpoint compared to 44% of those receiving the active agent (P = 1.00). In CD 45% of those receiving the active agent achieved the endpoint compared to 29% of those receiving placebo (P = 0.34). The mean change in IBS-SSS for patients receiving placebo was a reduction of 61 points, compared to a reduction in 90 points for patients receiving active agent (P = 0.31). There was no difference between the groups with regard to IBD outcomes. CONCLUSION: Probiotics may represent a safe and effective means of addressing the unmet clinical need for symptom relief in patients with overlapping IBS and IBD, especially in those with CD.