Diarrhoea
Conditions
Keywords
Clostridium difficile associated diarrhoea, antibiotic 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 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.
Interventions
DRUGVSL#3
Patients will o receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.
DRUGPlacebo
Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.
Sponsors
Wrightington, Wigan and Leigh NHS Foundation Trust
Ferring Pharmaceuticals
South London and Maudsley NHS Foundation Trust
North Bristol NHS Trust
Hull University Teaching Hospitals NHS Trust
National Health Service, United Kingdom
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of antibiotic associated diarrhoea | 28 days post last antibiotic dose |
| Development of Clostridium difficile associated diarrhoea | 28 days post last antibiotic dose |
Secondary
| Measure | Time frame |
|---|---|
| Length of Hospital Stay | 28 days post last antibiotic dose |
| 30-day Mortality | 30 days after initiation of therapy |
Countries
United Kingdom
Outcome results
None listed