A study into the effect of Lactobacillus casei Shirota in preventing antibiotic associated diarrhoea including Clostridioides difﬁcile infection in patients with spinal cord injuries: a multicentre randomised, double-blind, placebo-controlled trial

EClinicalMedicine, 2021 · DOI: https://doi.org/10.1016/j.eclinm.2021.101098 · Published: January 1, 2021

Spinal Cord Injury Gastroenterology Nutrition & Dietetics

Simple Explanation

This study investigated whether a specific probiotic, Lactobacillus casei Shirota (LcS), could prevent antibiotic-associated diarrhea (AAD) and Clostridioides difficile infection (CDI) in patients with spinal cord injuries (SCI). The trial involved multiple centers and used a randomized, double-blind, placebo-controlled design to ensure unbiased results. Patients were given either LcS or a placebo daily during their antibiotic course, followed by an additional 7 days. Researchers monitored the occurrence of AAD and CDI, along with other factors like proton pump inhibitor (PPI) use and nutritional status, to understand potential risk factors. The study found that while LcS did not prevent AAD/CDI in all SCI patients, it showed potential in preventing AAD in those who regularly took PPIs. This suggests that LcS might be beneficial for a specific subgroup of SCI patients at higher risk of AAD.

Study Duration

November 2014 to November 2019

Participants

359 consenting adult SCI patients

Evidence Level

Level 1: Multi-centre, randomized, double-blind, placebo-controlled trial

Key Findings

1
LcS did not significantly reduce the overall occurrence of AAD at 30 days in the entire SCI patient group (45% vs 42.1%, p = 0.639).
2
In patients who regularly used PPIs, LcS was associated with a significantly lower risk of AAD at both 7 days (19% vs 35.7%, p = 0.040) and 30 days (28% vs 52.2%, p = 0.015) follow-up.
3
Under-nutrition risk was associated with an increased risk of AAD at both 7 and 30 days follow-up (p < 0.001).

Research Summary

This multi-centre, double-blind, placebo-controlled trial assessed the efficacy of Lactobacillus casei Shirota (LcS) in preventing antibiotic-associated diarrhea (AAD) and Clostridioides difficile infection (CDI) in spinal cord injury (SCI) patients. The study found that LcS did not significantly reduce the overall incidence of AAD in the entire SCI patient cohort. However, a subgroup analysis revealed that LcS was associated with a lower risk of AAD in patients who regularly used proton pump inhibitors (PPIs). The study also identified under-nutrition risk as a significant factor associated with increased AAD risk. These findings suggest that LcS may be beneficial in specific high-risk subgroups, warranting further confirmatory studies.

Practical Implications

Targeted Probiotic Use

Consider LcS supplementation for SCI patients on regular PPI therapy to potentially reduce the risk of AAD.

Nutritional Screening

Implement routine nutritional screening for SCI patients undergoing antibiotic treatment to identify and manage those at higher risk of AAD.

Further Research

Conduct confirmatory studies with standardized AAD/CDI definitions to validate the potential benefits of LcS in high-risk SCI patient subgroups.

Study Limitations

1
Variations in infection control policies and AAD/CDI definitions across participating SCI centers.
2
The altered definition of AAD may have led to a failure in distinction between clinically relevant AAD and loose stool due to neurogenic bowel.
3
The study does not provide support for a general use of LcS to prevent AAD in SCI patients, only suggesting potential benefit in those on PPIs.

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