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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
231
Royal Albert Edward Infirmary
Wigan, Lancashire, United Kingdom
Queen Elizabeth Hospital
Woolwich, London, United Kingdom
Frenchay Hospital
Bristol, United Kingdom
Hull Royal Infirmary
Hull, United Kingdom
Development of antibiotic associated diarrhoea
Time frame: 28 days post last antibiotic dose
Development of Clostridium difficile associated diarrhoea
Time frame: 28 days post last antibiotic dose
Length of Hospital Stay
Time frame: 28 days post last antibiotic dose
30-day Mortality
Time frame: 30 days after initiation of therapy
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Weston General Hospital
Weston-super-Mare, United Kingdom