NCT00973908

Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: National Health Service, United Kingdom · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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. 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.

Conditions

• Diarrhoea

Interventions

Type	Name	Description
DRUG	VSL#3	Patients will o receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.
DRUG	Placebo	Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-04-01
• Completion: 2012-12-01
• First posted: 2009-09-09
• Last updated: 2013-04-26

Locations

5 sites across 1 country: United Kingdom