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

NCT00973908 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2013-04-26

No results posted yet for this study

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.

Conditions

  • Diarrhoea

Interventions

DRUG

VSL#3

Patients will o receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.

DRUG

Placebo

Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.

Sponsors & Collaborators

  • Wrightington, Wigan and Leigh NHS Foundation Trust

    collaborator OTHER

  • Ferring Pharmaceuticals

    collaborator INDUSTRY

  • South London and Maudsley NHS Foundation Trust

    collaborator OTHER

  • North Bristol NHS Trust

    collaborator OTHER

  • Hull University Teaching Hospitals NHS Trust

    collaborator OTHER_GOV

  • National Health Service, United Kingdom

    lead OTHER_GOV

Principal Investigators

  • Neil Haslam · Wirghtington Wigan and Leigh NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-04-30
Completion
2012-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00973908 on ClinicalTrials.gov