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

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ClinicalTrials.gov Identifier: NCT00973908
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : April 26, 2013
Sponsor:
Collaborators:
Wrightington, Wigan and Leigh NHS Foundation Trust
Ferring Pharmaceuticals
South London and Maudsley NHS Foundation Trust
North Bristol NHS Trust
Hull University Teaching Hospitals NHS Trust
Information provided by (Responsible Party):
Christian Selinger, National Health Service, United Kingdom

Tracking Information
First Submitted Date  ICMJE September 8, 2009
First Posted Date  ICMJE September 9, 2009
Last Update Posted Date April 26, 2013
Study Start Date  ICMJE April 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2009)
  • Development of antibiotic associated diarrhoea [ Time Frame: 28 days post last antibiotic dose ]
  • Development of Clostridium difficile associated diarrhoea [ Time Frame: 28 days post last antibiotic dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2012)
  • Length of Hospital Stay [ Time Frame: 28 days post last antibiotic dose ]
  • 30-day Mortality [ Time Frame: 30 days after initiation of therapy ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2009)
  • Length of Hospital Stay [ Time Frame: variable ]
  • 30-day Mortality [ Time Frame: 30 days after initiation of therapy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea
Official Title  ICMJE Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Diarrhoea
Intervention  ICMJE
  • 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.
    Other Names:
    • Bifidobacterium breve
    • Bifidobacterium longum
    • Bifidobacterium infantis
    • Lactobacillus acidophilus
    • Lactobacillus plantarum
    • Lactobacillus paracasei
    • Lactobacillus bulgaricus
    • Streptococcus thermophilus
  • Drug: Placebo
    Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.
    Other Name: Maltose based Placebo
Study Arms  ICMJE
  • Active Comparator: VSL#3
    Patients will receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.
    Intervention: Drug: VSL#3
  • Placebo Comparator: Placebo
    Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2013)
231
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2009)
450
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00973908
Other Study ID Numbers  ICMJE WWL - CDiff Prevention
EUDRACT 2008-005244-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christian Selinger, National Health Service, United Kingdom
Study Sponsor  ICMJE National Health Service, United Kingdom
Collaborators  ICMJE
  • Wrightington, Wigan and Leigh NHS Foundation Trust
  • Ferring Pharmaceuticals
  • South London and Maudsley NHS Foundation Trust
  • North Bristol NHS Trust
  • Hull University Teaching Hospitals NHS Trust
Investigators  ICMJE
Principal Investigator: Neil Haslam Wirghtington Wigan and Leigh NHS Trust
PRS Account National Health Service, United Kingdom
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP