Trial | NCT00973908  Report issue

Official Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    231
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 Started
Apr 30
2010
Primary Completion
Apr 30
2012
Study Completion
Dec 31
2012
Last Update
Apr 26
2013
Estimate

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.

  • Other names: Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus, Streptococcus thermophilus

Drug Placebo

Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.

  • Other names: Maltose based Placebo

VSL#3 Active Comparator

Patients will receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.

Placebo Placebo Comparator

Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.

Criteria 

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)
No Results Posted