Antibiotic associated/Clostridium difficile diarrhoea Infections and Infestations
Conditions
Interventions
Lactobacillus casei Shirota. One bottle of Yakult containing 6.5x10/9 Lactobacillus casei Shirota once a day during the course of antibiotics and for 7 days after the course finishes.
Sponsors
Buckinghamshire Healthcare NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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. Nil-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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of antibiotic-associated dairrhoea: Timepoint(s): 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Analyse the effect of LcS on: 1. Occurrence of C. difficile diarrhoea 2. Duration of diarrhoea 3. Gastrointestinal microbiota 4. Quality of life Measured 30 days after finishing probiotic/placebo. | — |
Countries
England, United Kingdom
Outcome results
None listed