Probiotics in the prevention of antibiotic-associated and C. difficile diarrhoea

Not Applicable

Completed

• Conditions: Antibiotic-associated diarrhoea; C. difficile diarrhoea; Infections and Infestations; Diarrhoea and gastroenteritis of presumed infectious origin

• Registration Number: ISRCTN70017204
• Lead Sponsor: Swansea University (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-31
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2974

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified