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

Samford Wong; Shashivadan P Hirani; Alastair Forbes; Naveen Kumar; Ramaswamy Hariharan; Jean O'Driscoll; Ravi Sekhar; Ali Jamous

doi:10.1038/s41393-024-00983-w

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

Spinal Cord. 2024 Mar 22. doi: 10.1038/s41393-024-00983-w. Online ahead of print.

Authors

Samford Wong^{1

2

3}, Shashivadan P Hirani⁴, Alastair Forbes⁵, Naveen Kumar⁶, Ramaswamy Hariharan⁷, Jean O'Driscoll⁸, Ravi Sekhar⁹, Ali Jamous¹⁰

Affiliations

¹ National Spinal Injuries Centre, Stoke Mandeville Hospital, Aylesbury, UK. samford.wong.1@city.ac.uk.
² School of Health & Psychological Sciences, City, University of London, London, UK. samford.wong.1@city.ac.uk.
³ Royal Buckinghamshire Hospital, Aylesbury, UK. samford.wong.1@city.ac.uk.
⁴ School of Health & Psychological Sciences, City, University of London, London, UK.
⁵ University of Tartu, Estonia, and Norwich Medical School, University of East Anglia, Norwich, UK.
⁶ Midland Centre for Spinal Injury, Robert Jones and Agnes Hunt Orthopaedic Hospital, Gobowen, UK.
⁷ The Princess Royal Spinal Injuries Centre, Northern General Hospital, Sheffield, UK.
⁸ Department of Microbiology, Stoke Mandeville Hospital, Aylesbury, UK.
⁹ Department of Gastroenterology, Stoke Mandeville Hospital, Aylesbury, UK.
¹⁰ INRES Neuro, Wendover, UK.

PMID: 38519563
DOI: 10.1038/s41393-024-00983-w

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 × 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 PPI. A confirmatory, randomised, placebo-controlled study is needed to confirm this apparent therapeutic success to translate it into appropriate clinical outcomes.

Sponsorship: Yakult Honsha Co., Ltd.