Clinical Trial: Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea

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 Clostridium Difficile associated diarrhoea.

Detailed Summary:

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.


Sponsor: National Health Service, United Kingdom

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of Hospital Stay [ Time Frame: 28 days post last antibiotic dose ]
  • 30-day Mortality [ Time Frame: 30 days after initiation of therapy ]


Original Secondary Outcome:

  • Length of Hospital Stay [ Time Frame: variable ]
  • 30-day Mortality [ Time Frame: 30 days after initiation of therapy ]


Information By: National Health Service, United Kingdom

Dates:
Date Received: September 8, 2009
Date Started: April 2010
Date Completion:
Last Updated: April 25, 2013
Last Verified: April 2013