A multicentre, randomised, placebo controlled trial of lactic acid bacteria in the prevention of antibiotic-associated diarrhoea (AAD) and Clostridium difficile diarrhoea (CDD) in patients aged 65 years and over admitted to hospital and receiving antibiotics (06/39/02)
Phase 1
- Conditions
- AAD is diarrhoea occurring in association with antibiotic treatment without an alternative cause. It occurs typically 2-8 weeks after exposure to antibiotics. The frequency of AAD varies markedly between studies according to risk factors such as exposure to broad-spectrum antibiotics, nosocomial infections and host factors such as age, health status, gender.MedDRA version: 9.1 Level: PT Classification code 10064065 Term: Prophylaxis against diarrhoea
- Registration Number
- EUCTR2007-002876-32-GB
- Lead Sponsor
- niversity of Wales Swansea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 2974
Inclusion Criteria
•People aged =65 years admitted to hospital without diarrhoea and who have been exposed to one or more antibiotics within the last 7 days or are about to start antibiotic treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
•People with known immunosuppressive disorder, prosthetic heart valve or active inflammatory bowel disease (the latter defined as requiring specific treatment in the past 12 months)
•People with a previous history of adverse reactions to probiotics
•Informed consent not granted by patient or their carer(s)
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