PMID- 38519563 OWN - NLM STAT- Publisher LR - 20240323 IS - 1476-5624 (Electronic) IS - 1362-4393 (Linking) DP - 2024 Mar 22 TI - 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. LID - 10.1038/s41393-024-00983-w [doi] AB - 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 10(9) 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. CI - (c) 2024. Crown. FAU - Wong, Samford AU - Wong S AUID- ORCID: 0000-0002-3975-5684 AD - National Spinal Injuries Centre, Stoke Mandeville Hospital, Aylesbury, UK. samford.wong.1@city.ac.uk. AD - School of Health & Psychological Sciences, City, University of London, London, UK. samford.wong.1@city.ac.uk. AD - Royal Buckinghamshire Hospital, Aylesbury, UK. samford.wong.1@city.ac.uk. FAU - Hirani, Shashivadan P AU - Hirani SP AD - School of Health & Psychological Sciences, City, University of London, London, UK. FAU - Forbes, Alastair AU - Forbes A AD - University of Tartu, Estonia, and Norwich Medical School, University of East Anglia, Norwich, UK. FAU - Kumar, Naveen AU - Kumar N AD - Midland Centre for Spinal Injury, Robert Jones and Agnes Hunt Orthopaedic Hospital, Gobowen, UK. FAU - Hariharan, Ramaswamy AU - Hariharan R AD - The Princess Royal Spinal Injuries Centre, Northern General Hospital, Sheffield, UK. FAU - O'Driscoll, Jean AU - O'Driscoll J AD - Department of Microbiology, Stoke Mandeville Hospital, Aylesbury, UK. FAU - Sekhar, Ravi AU - Sekhar R AD - Department of Gastroenterology, Stoke Mandeville Hospital, Aylesbury, UK. FAU - Jamous, Ali AU - Jamous A AD - INRES Neuro, Wendover, UK. LA - eng PT - Journal Article DEP - 20240322 PL - England TA - Spinal Cord JT - Spinal cord JID - 9609749 SB - IM EDAT- 2024/03/23 20:43 MHDA- 2024/03/23 20:43 CRDT- 2024/03/23 00:32 PHST- 2023/06/13 00:00 [received] PHST- 2024/03/13 00:00 [accepted] PHST- 2024/03/08 00:00 [revised] PHST- 2024/03/23 20:43 [medline] PHST- 2024/03/23 20:43 [pubmed] PHST- 2024/03/23 00:32 [entrez] AID - 10.1038/s41393-024-00983-w [pii] AID - 10.1038/s41393-024-00983-w [doi] PST - aheadofprint SO - Spinal Cord. 2024 Mar 22. doi: 10.1038/s41393-024-00983-w.