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Probiotics in the prevention of antibiotic-associated and C. difficile diarrhoea
DOI 10.1186/ISRCTN70017204
ClinicalTrials.gov identifier
EudraCT number
Public title Probiotics in the prevention of antibiotic-associated and C. difficile diarrhoea
Scientific title A multicentre, randomised, placebo controlled trial of lactic acid bacteria and bifidobacteria 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
Serial number at source HTA 06/39/02
Study hypothesis A probiotic food supplement is effective in preventing antibiotic-associated and Clostridium difficile diarrhoea in older people admitted to hospital and receiving antibiotics.
Lay summary Not provided at time of registration
Ethics approval Research Ethics Committee for Wales, 27/11/2008
Study design Multicentre randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Antibiotic-associated diarrhoea; C. difficile diarrhoea
Participants - inclusion criteria 1. People aged greater than or equal to 65 years, either sex
2. Admitted to hospital without diarrhoea
3. Have been exposed to one or more antibiotics within the last 7 days or are about to start antibiotic treatment
Participants - exclusion criteria 1. 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)
2. Acute pancreatitis (defined as abdominal pain with serum amylase or lipase concentration greater than or equal to three times the institutional upper limit of normal)
3. Jejunal tube in-situ and/or jejunal feeding (as documented in the clinical/nursing records)
4. Likely impaired splanchnic perfusion: any past or current abnormality or disease affecting the mesenteric arteries (as documented in the clinical records)
5. Severe illness requiring care in either a high dependency or intensive care unit (but not planned admission to these facilities for observation only, e.g., after cardiac surgery)
6. People with a previous history of adverse reactions to probiotics
7. Informed consent not granted by patient or their carer(s)
Anticipated start date 01/12/2008
Anticipated end date 01/03/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 2,974
Interventions 1. Live bacteria of human origin: 2 strains of Lactobacillus acidophilus (CUL60, National Collection of Industrial, Food and Marine Bacteria [NCIMB] 30157 and CUL21, NCIMB 30156), Bifidobacterium bifidum (CUL20, NCIMB 30153), Bifidobacterium lactis (CUL34, NCIMB 30172). Prepared as lyophilised powder in a capsule containing 6 x 1010 organisms/capsule.
2. Identical formulation of inert placebo: maltodextrin

The dose of probiotic is prepared in 5 g lyophilised powder in a capsule - the placebo is a matched capsule with 5 g of maltodextrin. Dosing is daily for 21 days via the oral route. The total duration of follow-up is 8 weeks from the end of antibiotics to a maximum of 12 weeks if other courses of antibiotics are given.
Primary outcome measure(s) During antibiotic treatment and within 8 weeks of stopping antibiotics:
1. The occurrence of antibiotic associated diarrhoea (AAD)
2. The occurrence of C. difficile diarrhoea (CDD)
Secondary outcome measure(s) 1. Severity and duration of AAD
2. Abdominal symptoms (abdominal pain, bloating, flatus, nausea)
3. Severity and duration of CDD and incidence of recurrence within the study period
4. Incidence of pseudomembranous colitis (PMC), need for colectomy, death
5. Well-being and quality of life
6. Duration of hospital stay
7. Adverse effects
8. Acceptability of the probiotic preparation
9. Viability of the probiotic at point of administration
All of these outcomes will be measured during the period from participant recruitment to 8 weeks after stopping antibiotics, to a maximum of 12 weeks from recruitment.

10. Risk factors for ADD, CDD and severe disease (PMC, colectomy, death), assessed at participant recruitment
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22559011
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23932219
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24309198
Contact name Miss  Kathie  Wareham
  Address Clinical Research Unit
Morriston Hospital
  City/town Swansea
  Zip/Postcode SA6 6NL
  Country United Kingdom
  Tel +44 (0)1792 703722
  Fax +44 (0)1792 704011
  Email kathie.wareham@swansea-tr.wales.nhs.uk
Sponsor Swansea University (UK)
  Address Singleton Park
  City/town Swansea, West Glamorgan
  Zip/Postcode SA2 8PP
  Country United Kingdom
  Tel +44 (0)1792 205678
  Fax +44 (0)1792 295157
  Email c.d.jones@swansea.ac.uk
  Sponsor website: http://www.swansea.ac.uk
Date applied 03/04/2009
Last edited 08/08/2014
Date ISRCTN assigned 31/07/2009
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