Status:
COMPLETED
Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea
Lead Sponsor:
National Health Service, United Kingdom
Collaborating Sponsors:
Wrightington, Wigan and Leigh NHS Foundation Trust
Ferring Pharmaceuticals
Conditions:
Diarrhoea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 Clostri...
Detailed Description
The investigators aim to find out whether VSL#3 can prevent Antibiotic associated diarrhoea and Clostridium Difficile associated diarrhoea when VSL#3 is giving during a course of systemic antibiotics....
Eligibility Criteria
Inclusion
- Adults aged 18 or older
- Hospital inpatients
- On systemic antibiotics for an infection
- Antibiotics started within last 48 hours
Exclusion
- Diarrhoea at screening
- Unable to take enteral meds
- Patients on intensive care units
- Severe Immunosuppression (neutropenia, AIDS, congenital immunoparesis, chemotherapy)
- Risk of endocarditis (Artificial heart valves, history of rheumatic heart disease or infective endocarditis)
- Regular consumption of probiotics until 1 week prior to admission
- Acute severe pancreatitis Persistent vomiting (two days or more)
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT00973908
Start Date
April 1 2010
End Date
December 1 2012
Last Update
April 26 2013
Active Locations (5)
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1
Royal Albert Edward Infirmary
Wigan, Lancashire, United Kingdom, WN1 2NN
2
Queen Elizabeth Hospital
Woolwich, London, United Kingdom, SE18 4QH
3
Frenchay Hospital
Bristol, United Kingdom, BS16 1LE
4
Hull Royal Infirmary
Hull, United Kingdom, HU3 2JZ