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

This study has been completed.
Sponsor:
Collaborators:
Wrightington, Wigan and Leigh NHS Foundation Trust
Ferring Pharmaceuticals
South London and Maudsley NHS Foundation Trust
North Bristol NHS Trust
Hull and East Yorkshire Hospitals NHS Trust
Information provided by (Responsible Party):
Christian Selinger, National Health Service, United Kingdom
ClinicalTrials.gov Identifier:
NCT00973908
First received: September 8, 2009
Last updated: April 25, 2013
Last verified: April 2013

September 8, 2009
April 25, 2013
April 2010
April 2012   (final data collection date for primary outcome measure)
  • Development of antibiotic associated diarrhoea [ Time Frame: 28 days post last antibiotic dose ] [ Designated as safety issue: No ]
  • Development of Clostridium difficile associated diarrhoea [ Time Frame: 28 days post last antibiotic dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00973908 on ClinicalTrials.gov Archive Site
  • Length of Hospital Stay [ Time Frame: 28 days post last antibiotic dose ] [ Designated as safety issue: No ]
  • 30-day Mortality [ Time Frame: 30 days after initiation of therapy ] [ Designated as safety issue: Yes ]
  • Length of Hospital Stay [ Time Frame: variable ] [ Designated as safety issue: No ]
  • 30-day Mortality [ Time Frame: 30 days after initiation of therapy ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea
Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Diarrhoea
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
231
December 2012
April 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00973908
WWL - CDiff Prevention, EUDRACT 2008-005244-16
Yes
Christian Selinger, National Health Service, United Kingdom
National Health Service, United Kingdom
  • Wrightington, Wigan and Leigh NHS Foundation Trust
  • Ferring Pharmaceuticals
  • South London and Maudsley NHS Foundation Trust
  • North Bristol NHS Trust
  • Hull and East Yorkshire Hospitals NHS Trust
Principal Investigator: Neil Haslam Wirghtington Wigan and Leigh NHS Trust
National Health Service, United Kingdom
April 2013

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