Diarrhoea Clinical Trial
Official title:
Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea
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.
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. Patients will be randomized in a 1:1 proportion to receive either one
sachet of VSL#3 or a similar looking placebo twice a day. This will be given for the length
of the antibiotic course and another week thereafter. Follow-up will last until 28 days
after the last antibiotic dose. Patient restarted on antibiotics during follow-up will be
restarted on the trial medication and the 28 day follow-up will be recommenced.
This trial has 2 co-primary outcome measures.
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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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