Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators aim to investigate whether the routine use of the probiotic formulation VSL#3 co-prescribed with antibiotics reduces the incidence of both Antibiotic associated diarrhoea and Clostridium Difficile associated diarrhoea.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Health Service, United Kingdom
• Collaborators: Ferring Pharmaceuticals; Hull and East Yorkshire Hospitals NHS Trust; Hull University Teaching Hospitals NHS Trust; North Bristol NHS Trust; South London and Maudsley NHS Foundation Trust; Wrightington, Wigan and Leigh NHS Foundation Trust
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular

Criteria

Inclusion Criteria:

• Adults aged 18 or older

• Hospital inpatients

• On systemic antibiotics for an infection

• Antibiotics started within last 48 hours

Exclusion Criteria:

• Diarrhoea at screening

• Unable to take enteral meds

• Patients on intensive care units

• Severe Immunosuppression (neutropenia, AIDS, congenital immunoparesis, chemotherapy)

• Risk of endocarditis (Artificial heart valves, history of rheumatic heart disease or infective endocarditis)

• Regular consumption of probiotics until 1 week prior to admission

• Acute severe pancreatitis Persistent vomiting (two days or more)