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Randomized Controlled Trial
. 2024 May;62(5):255-263.
doi: 10.1038/s41393-024-00983-w. Epub 2024 Mar 22.

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  1   2   3 , Shashivadan P Hirani  4 , Alastair Forbes  5 , Naveen Kumar  6 , Ramaswamy Hariharan  7 , Jean O'Driscoll  8 , Ravi Sekhar  9 , Ali Jamous  10
Affiliations
Randomized Controlled Trial

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 et al. Spinal Cord. 2024 May.

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.

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Conflict of interest statement

SW has received funding support from Yakult Honsha Co Ltd. Yakult Europe B.V. provided free LcS/Placebo and the necessary equipment to maintain the cold chain. The company was aware of, but did not influence the trial design, and had no role in data analysis and interpretation. AF has received honoraria form Fresenius Kabi, Takeda and Dr Falk Pharma. SW as chief investigator and corresponding author had full access to the final dataset and made final decision to submit for publication.

Figures

Fig. 1
Fig. 1. Trial Profile.
Decision tree for recruitment and randomisation.
Fig. 2
Fig. 2
ECLISP outcome summary.
See this image and copyright information in PMC

References

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