drugset / Trial / NCT00973908
Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea
Phase 2/3
Completed
231 enrolled
National Health Service, United Kingdom
Ferring Pharmaceuticals · collabHull University Teaching Hospitals NHS Trust · collabNorth Bristol NHS Trust · collabSouth London and Maudsley NHS Foundation Trust · collabWrightington, Wigan and Leigh NHS Foundation Trust · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The investigators aim to investigate whether the routine use of the probiotic formulation VSL#3 co-prescribed with antibiotics reduces the incidence of both Antibiotic associated diarrhoea and Clostridium Difficile associated diarrhoea.
Timeline
- Start
- 2010-04
- Primary completion
- 2012-04
- Completion
- 2012-12
Publications
- Background Bergogne-Berezin E. Treatment and prevention of antibiotic associated diarrhea. Int J Antimicrob Agents. 2000 Dec;16(4):521-6. doi: 10.1016/s0924-8579(00)00293-4.
- Background D'Souza AL, Rajkumar C, Cooke J, Bulpitt CJ. Probiotics in prevention of antibiotic associated diarrhoea: meta-analysis. BMJ. 2002 Jun 8;324(7350):1361. doi: 10.1136/bmj.324.7350.1361.
- Background Cremonini F, Di Caro S, Nista EC, Bartolozzi F, Capelli G, Gasbarrini G, Gasbarrini A. Meta-analysis: the effect of probiotic administration on antibiotic-associated diarrhoea. Aliment Pharmacol Ther. 2002 Aug;16(8):1461-7. doi: 10.1046/j.1365-2036.2002.01318.x.
- Results Selinger CP, Bell A, Cairns A, Lockett M, Sebastian S, Haslam N. Probiotic VSL#3 prevents antibiotic-associated diarrhoea in a double-blind, randomized, placebo-controlled clinical trial. J Hosp Infect. 2013 Jun;84(2):159-65. doi: 10.1016/j.jhin.2013.02.019. Epub 2013 Apr 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | VSL#3 | Other / unclassified | — | — |