Probiotics for the prevention of antibiotic-associated diarrhoea and Clostridium difficile associated diarrhoea
| ISRCTN | ISRCTN19604441 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19604441 |
| EudraCT/CTIS number | 2008-005244-16 |
| ClinicalTrials.gov number | NCT00973908 |
| Secondary identifying numbers | 8157 |
- Submission date
- 21/10/2010
- Registration date
- 21/10/2010
- Last edited
- 01/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Christian Selinger
Scientific
Scientific
Wrightington, Wigan and Leigh NHS Foundation Trust
Endoscopy Unit
Wigan Lane
Wigan
WN1 2NN
United Kingdom
| christian.selinger@web.de |
Study information
| Study design | Multicentre randomised interventional phase II prevention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Probiotics for the prevention of antibiotic associated diarrhoea and Clostridium difficile associated diarrhoea: a multicentre randomised interventional phase II prevention trial |
| Study objectives | The study aims to establish whether VSL#3 compared to placebo prevents antibiotic-associated diarrhoea and Clostridium difficile associated diarrhoea in hospitalised patients on systemic antibiotics. |
| Ethics approval(s) | North Staffordshire Local Research Ethics Committee 3 approved on the 22nd April 2010 (ref: 08/H1201/147) |
| Health condition(s) or problem(s) studied | Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Gastrointestinal |
| Intervention | Intervention: 1 sachet of VSL#3 twice daily for the duration of the antibiotic course and seven days thereafter. Control: 1 sachet of placebo twice daily for the duration of the antibiotic cource and seven days thereafter. Follow-up until 28 days after the last antibiotic dose. Study entry: single randomisation only |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | VSL#3 |
| Primary outcome measure | Development of CDAD, measured at 28 days after last antibiotic dose |
| Secondary outcome measures | 1. 30 day mortality 2. Development of AAD, measured at 28 days post-last antibiotic dose 3. Length of hospital stay |
| Overall study start date | 01/04/2010 |
| Completion date | 10/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 445; UK sample size: 445 |
| Key inclusion criteria | 1. Systemic antibiotics 2. Aged 18 years or older, either sex 3. Able to take enteral medication (sachets) |
| Key exclusion criteria | 1. Diarrhoea at screening 2. Unable to take enteral medication 3. Patients on intensive care units 4. Severe immunosuppression (neutropenia, acquired immunodeficiency syndrome [AIDS], congenital immunoparesis, chemotherapy) 5. Risk of endocarditis (artificial heart valves, history of rheumatic heart disease or infective endocarditis) 6. Regular consumption of probiotics until 1 week prior to admission 7. Acute severe pancreatitis 8. Persistent vomiting (two days or more) |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 10/03/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan
WN1 2NN
United Kingdom
WN1 2NN
United Kingdom
Sponsor information
Wrightington, Wigan and Leigh NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Clinical Trials Unit
Hall Lane
Appley Bridge
Wigan
WN6 9EP
England
United Kingdom
| Website | http://www.wiganleigh.nhs.uk |
|---|---|
"ROR" |
https://ror.org/028mrxf52 |
Funders
Funder type
Industry
Ferring Pharmaceuticals Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2013 | Yes | No |
