Probiotics’ effects on perception of health and bowel frequency: a double-blind, randomised, placebo-controlled clinical trial

Methods

The VSL#3 Probiotic (V3P; Visbiome in USA; Vivomixx in EU) contains eight strains of live, freeze-dried lactic acid bacteria. It has some therapeutic potential in ulcerative colitis and pouchitis. Healthy volunteers of age 18 years and above were invited to join the study. Excluded were individuals who had antibiotics 6 weeks or probiotics 4 weeks prior to recruitment and those with chronic gastrointestinal diseases except for irritable bowel syndrome. 83 individuals were recruited and randomised blindly, 42 to the V3P group and 41 to the placebo group. Each individual was given either placebo or probiotics to be taken twice daily for 4 weeks. One individual assigned to the V3P group did not attend any visit following the start of the trial. Individuals’ perception of health and bowel frequency was assessed during three visits (week 0, week 4 and week 8). Individuals’ perception of health was assessed using EQ-5D, which is a standardised tool that provides a simple descriptive profile and a single index value for health status. The analysis was done using SPSS version 23. Intention to treat analysis was used; we compared mean scores of EQ-5D between the two groups using an independent t-test in each visit. A p-value was considered significant if less than 0.05.