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.

2024-03-22
Spinal cord 62(5)
- Samford Wong
- Shashivadan P Hirani
- Alastair Forbes
- Naveen Kumar
- Ramaswamy Hariharan
- Jean O'Driscoll
- Ravi Sekhar
- Ali Jamous

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

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 50
Population: 95 SCI patients on regular PPI
Methods: Multicentre, randomised, placebo-controlled, double-blind trial; LcS (≥6.5×10^9 CFU) or placebo once daily for antibiotic course plus 7 days
Blinding: Double-blind
Duration: antibiotic course plus 7 days
Funding: Industry-funded

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.

Research Insights

Lacticaseibacillus casei→Reduced Diarrhea Rate
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).
Effect
Beneficial
Effect size
Moderate
Dose
at least 6.5 × 10^9 live Lactobacillus casei Shirota (LcS) once daily

Adverse Events Reported

Lacticaseibacillus casei→Overall tolerability
No intervention-related adverse events were reported during the study.
Finding
Reported