Prevention of Clostridium Difficile associated diarrhoea. MedDRA version: 9.1 Level: LLT Classification code 10012748 Term: Diarrhoea, Clostridium difficile
Conditions
Interventions
Product Name: VSL#3
Pharmaceutical Form: Granules for oral solution
Other descriptive name: Lactobacillus plantarum
Concentration unit: billion organisms billion organisms
Other descriptive name: Lact
Sponsors
Wrightington, Wigan and Leigh NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All adult inpatients (18 years or older) at the Royal Albert Edward Infirmary, North Bristol NHS Trust, Hull Royal Infirmary, and Weston General Hospital receiving antibiotics for an infection can be screened for eligibility. The main target for eligibility screening will be the medical admissions unit of each hospital. All eligible patients on the medical admissions unit are to be identified by the ward staff who will inform the research nurse within 48 hrs. Inpatients on other hospital wards can be screened for eligibility and recruited (if research nurse has time to do so). Informed written consent will be obtained from competent individuals. Patients that lack capacity will be consented by the consultant in charge of their care in consultation with the relatives (equivalent to consent form 4) (We will specifically include patients having taken antibiotics prior to admission, patients on high-risk antibiotics and patients with bowel pathology (who do not have diarrhoea on presentation). All forms of systemic administration of antibiotics (iv, im, po) are eligible. Patients unable to consent for the trial themselves (dementia, aphasia etc.) shall be recruited to this trial as they are at very high risk of developing CDAD. We will seek guidance from the ethics committee on how to recruit these patients. Main inclusion criteria: *systemic antibiotics *18 years of age or older *able to take enteral medication Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: *Diarrhoea at screening: End point *Unable to take enteral meds: Required for administration of probiotic *Patients on intensive care units: Ethical issue around consent *Severe Immunosuppression (neutropenia, AIDS, congenital immunoparesis, chemotherapy): Theoretical risk of probiotic induced infection *Risk of endocarditis (Artificial heart valves, history of rheumatic heart disease or infective endocarditis): Theoretical risk of probiotic induced infection *Regular consumption of probiotics until 1 week prior to admission: Likely confounder *Persistent vomiting (two days or more): Would prevent administration of probiotic *acute pancreatitis: Reported adverse outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We aim to investigate whether the routine use of probiotics co-prescribed with antibiotics reduces the incidence of both AAD and CDAD. ;Secondary Objective: Secondary outcomes are 30 day mortality and length of hospital stay.;Primary end point(s): Primary endpoints will be the development of AAD and development of CDAD. Secondary endpoints will be length of hospital stay and 30-day mortality. | — |
Countries
United Kingdom
Outcome results
None listed