Efficacy of Consuming LcS In Spinal cord injury Patients (ECLISP)
- Conditions
- Antibiotic associated/Clostridium difficile diarrhoeaInfections and Infestations
- Registration Number
- ISRCTN13119162
- Lead Sponsor
- Buckinghamshire Healthcare NHS Trust
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 359
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of antibiotic-associated dairrhoea: Timepoint(s): 30 days
- Secondary Outcome Measures
Name Time Method Analyse the effect of LcS on:<br>1. Occurrence of C. difficile diarrhoea<br>2. Duration of diarrhoea<br>3. Gastrointestinal microbiota<br>4. Quality of life<br><br>Measured 30 days after finishing probiotic/placebo.