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

Phase 2

Completed

• Conditions: Diarrhoea
• Interventions: Drug: VSL#3; Drug: Placebo

• Registration Number: NCT00973908
• Lead Sponsor: National Health Service, United Kingdom

Brief 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.

Detailed Description

The investigators aim to find out whether VSL#3 can prevent Antibiotic associated diarrhoea and Clostridium Difficile associated diarrhoea when VSL#3 is giving during a course of systemic antibiotics. Patients will be randomized in a 1:1 proportion to receive either one sachet of VSL#3 or a similar looking placebo twice a day. This will be given for the length of the antibiotic course and another week thereafter. Follow-up will last until 28 days after the last antibiotic dose. Patient restarted on antibiotics during follow-up will be restarted on the trial medication and the 28 day follow-up will be recommenced.

This trial has 2 co-primary outcome measures.

Study Timeline

• Study First Submitted: 2009-09-08
• Study First Submitted QC: 2009-09-08
• Study First Posted: 2009-09-09
• Study Start: 2010-04
• Primary Completion: 2012-04
• Study Completion: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VSL#3	VSL#3	Patients will receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.
Placebo	Placebo	Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.

Primary Outcome Measures

Name	Time	Method
Development of antibiotic associated diarrhoea	28 days post last antibiotic dose
Development of Clostridium difficile associated diarrhoea	28 days post last antibiotic dose

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	28 days post last antibiotic dose
30-day Mortality	30 days after initiation of therapy

Trial Locations

Locations (5)

Royal Albert Edward Infirmary; 🇬🇧 Wigan, Lancashire, United Kingdom

Queen Elizabeth Hospital; 🇬🇧 Woolwich, London, United Kingdom

Frenchay Hospital; 🇬🇧 Bristol, United Kingdom

Hull Royal Infirmary; 🇬🇧 Hull, United Kingdom

Weston General Hospital; 🇬🇧 Weston-super-Mare, United Kingdom