THE PROBIOTICS FOR ANTIBIOTIC ASSOCIATED DIARRHOEA (PAAD) STUDY Stage II : A double blind randomised placebo controlled trial to determine the effect of probiotics on antibiotic associated diarrhoea in care home residents.
- Conditions
- Antibiotic Associated DiarrhoeaMedDRA version: 14.1 Level: LLT Classification code 10055956 Term: Antibiotic-associated diarrhoea System Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Body processes [G] - Microbiological Phenomena [G06]
- Registration Number
- EUCTR2011-006269-17-GB
- Lead Sponsor
- Cardiff University, Research & Development Commercial Department
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
INCLUSION CRITERIA
•Resident in a care home for 24 hours or more, with a minimum planned residential care of 1 month.
•Able to provide informed consent or have a personal legal representative who can provide consent for inclusion.
•If the SU takes a regular probiotic but chooses to discontinue the probiotic
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400
EXCLUSION CRITERIA
•Severely immuno-compromised, e.g. known severe neutropenia
•Has artificial heart valve in situ.
•Medical history of acute pancreatitis.
•Requires naso-jejunal feeding /nasogastric feeding due to difficulty of administering probiotic.
•Currently has a colostomy.
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