Lactobacillus casei Shirota probiotic drinks reduce antibiotic associated diarrhoea in patients with spinal cord injuries who regularly consume proton pump inhibitors: a subgroup analysis of the ECLISP multicentre RCT

STUDY DESIGN: This was a sub-group analysis of a multicentre, randomised, placebo-controlled, double-blind trial (ECLISP trial) OBJECTIVES: To assess the efficacy of a probiotic containing at least 6.5 x 109liveLactobacillus caseiShirota (LcS) in preventingantibiotic associated diarrhoea (AAD) in patients with spinal cord injury (SCI) who consumed proton pump inhibitor (PPI) regularly.LcS or placebo was given once daily for the duration of an antibiotic course and continued for 7 days thereafter. The trial wasregistered with ISRCTN:13119162. SETTING: Three SCI centres (National Spinal Injuries Centre, Midland Centre for Spinal Injuries and Princess Royal Spinal CordInjuries Centre) in the United Kingdom METHODS: Between November 2014, and November 2019, 95 eligible consenting SCI patients (median age: 57; IQ range: 43-69)were randomly allocated to receive LcS (n=50) or placebo (n=45). The primary outcome is the occurrence of AAD up to 30 days after finishing LcS/placebo. RESULTS: The LcS group had a significantly lower incidence of AAD at 30 days after finishing the antibiotic course (28.0 v 53.3%, RR:95% CI: 0.53, 0.31-0.89; z=2.5,p=0.01). Multivariate logistic regression analysis identified that LcS can reduce the risk of AAD at30 days (OR: 0.36, 95% CI 0.13, 0.99,p< 0.05). No intervention-related adverse events were reported during the study. CONCLUSIONS: LcS has the potential to prevent AAD in what could be considered a defined vulnerable group of SCI patients onregular PPI. A confirmatory, randomised, placebo-controlled study is needed to confirm this apparent therapeutic success totranslate it into appropriate clinical outcomes.