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

2014-07-23 21:13:24 | BioPortfolio

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.

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 Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Diarrhoea

Intervention

VSL#3, Placebo

Location

Royal Albert Edward Infirmary
Wigan
Lancashire
United Kingdom
WN1 2NN

Status

Not yet recruiting

Source

National Health Service, United Kingdom

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:24-0400

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