Probiotics for the prevention of Antibiotics associated diarrhoea andClostridium difficile associated diarrhoeaA multi-centre, double-blind, randomized placebo controlled trial
- Conditions
- Prevention of Clostridium Difficile associated diarrhoea.MedDRA version: 9.1Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficile
- Registration Number
- EUCTR2008-005244-16-GB
- Lead Sponsor
- Wrightington, Wigan and Leigh NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
*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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method