Title : Treating irritable bowel syndrome patients with a balanced multi-strain synbiotic – results from a multi-center, randomized, double-blind, placebo-controlled clinical trial (the ViIBS trial)
Abstract:
Effects of a balanced multi-strain synbiotic in patients with moderate to severe irritable bowel syndrome (IBS) of all stool form types were characterized in a multi-center, randomized, double blind, placebo-controlled clinical study. A total of 202 adult IBS patients were randomized (1:1) and, after a four-week treatment-free run-in phase, were treated either with the balanced multi-strain synbiotic or a placebo for 12 weeks.
Primary endpoints of the trial were
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(1) assessment of the severity of IBS symptoms (IBS-SSS)
- (2) the improvement of IBS global symptoms (IBS-GIS).
Secondary endpoints comprised adequate relief (IBS-AR scale), stool form type (Bristol Stool Form Scale), severity of abdominal pain and bloating, stool pressure, feeling of incomplete stool evacuation, and adverse events. A total of 201 patients completed the study. Synbiotic treatment, in comparison to placebo, significantly improved IBS-SSS and IBS-GIS scores. After the end of the treatment, 70% of patients in the synbiotic group (0% in the placebo group) achieved adequate relief. After 12 weeks of treatment, the secondary endpoints were favourably differentiated in the synbiotic group when compared with the placebo group. Two patients in the synbiotic group reported transient adverse events (headache). The results indicate that treatment of IBS patients with the synbiotic significantly improved all major symptoms of IBS and was well-tolerated.
