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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
NCT00973908 |
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Date of registration:
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08/09/2009 |
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Primary sponsor: |
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Public title:
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Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea
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Scientific title:
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Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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231 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00973908 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Neil Haslam |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wirghtington Wigan and Leigh NHS Trust |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adults aged 18 or older
- Hospital inpatients
- On systemic antibiotics for an infection
- Antibiotics started within last 48 hours
Exclusion Criteria:
- 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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diarrhoea
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Intervention(s)
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Drug: Placebo
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Drug: VSL#3
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Primary Outcome(s)
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Development of antibiotic associated diarrhoea
[Time Frame: 28 days post last antibiotic dose]
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Development of Clostridium difficile associated diarrhoea
[Time Frame: 28 days post last antibiotic dose]
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Secondary Outcome(s)
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30-day Mortality
[Time Frame: 30 days after initiation of therapy]
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Length of Hospital Stay
[Time Frame: 28 days post last antibiotic dose]
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Secondary ID(s)
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EUDRACT 2008-005244-16
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WWL - CDiff Prevention
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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