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Abstract

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 109 live Lactobacillus casei Shirota (LcS) in preventing antibiotic 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 was registered with ISRCTN:13119162.

Setting
Three SCI centres (National Spinal Injuries Centre, Midland Centre for Spinal Injuries and Princess Royal Spinal Cord Injuries 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 at 30 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 on regular PPL A confirmatory, randomised, placebo-controlled study is needed to confirm this apparent therapeutic success to translate it into appropriate clinical outcomes.

Publication Type:	Article
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Publisher Keywords:	Clostridium difficile, Nutrition, Nutritional supplements
Subjects:	Q Science > QR Microbiology R Medicine > RC Internal medicine
Departments:	School of Health & Psychological Sciences School of Health & Psychological Sciences > Healthcare Services Research & Management
SWORD Depositor:	Symplectic Administrator

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