Effect of Lactobacillus casei Shirota in preventing antibiotic associated diarrhoea (AAD) including Clostridium difficile associated diarrhoea (CDAD) in patients with spinal cord injuries: a multicentre, randomised, double-blind, placebo-controlled trial

Buckinghamshire Healthcare NHS Trust0 个研究点目标入组 359 人开始时间: 2015年1月12日最近更新: 2024年4月8日

试验速览

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34541475/ results (added 21/09/2021) 2024 Results article in https://doi.org/10.1038/s41393-024-00983-w (added 25/03/2024)

•1. Adult (=18 years)
•2. Patient is likely to remain in the Spinal Cord Injury Centre (SCIC) for more than 6 weeks can be included
•3. Newly started antibiotics (for a minimum of 3 days) (single or multiple)

•1. Re-recruit patient (1st recruitment only)
•2. Antibiotics for prophylaxis use
•3. Diarrhoea prior to recruitment
•4. Bowel pathology that could result in diarrhoea
•5. Recent bowel surgery
•6. Infective endocarditis
•7. Active inflammatory bowel disease
•8. Pancreatitis
•9. Regular probiotic use
•10. Antibiotic use in the 30 days prior to the study product first administration
•11. Severe illness
•12. Immunosuppression
•13. -by-mouth status for any reason
•14. Non?functioning gut
•15. Known cows? milk protein intolerance
•16. Psychiatric or cognitive conditions that may interfere with the study
•17. Patients incapable of providing informed consent
•18. Patients unlikely to comply with study requirements
•19. Pregnant or breastfeeding women
•20. Prisoners

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