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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
  Purpose

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.


Condition Intervention Phase
Diarrhoea
Drug: VSL#3
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea

Resource links provided by NLM:


Further study details as provided by National Health Service, United Kingdom:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 231
Study Start Date: April 2010
Study Completion Date: December 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Placebo Comparator: Placebo
Patients will one placebo sachet 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.
Other Name: Maltose based Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973908

Locations
United Kingdom
Royal Albert Edward Infirmary
Wigan, Lancashire, United Kingdom, WN1 2NN
Queen Elizabeth Hospital
Woolwich, London, United Kingdom, SE18 4QH
Frenchay Hospital
Bristol, United Kingdom, BS16 1LE
Hull Royal Infirmary
Hull, United Kingdom, HU3 2JZ
Weston General Hospital
Weston-super-Mare, United Kingdom, BS23 4TQ
Sponsors and Collaborators
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
Investigators
Principal Investigator: Neil Haslam Wirghtington Wigan and Leigh NHS Trust
  More Information

Publications:
Responsible Party: Christian Selinger, Coordinating investigator, National Health Service, United Kingdom
ClinicalTrials.gov Identifier: NCT00973908     History of Changes
Other Study ID Numbers: WWL - CDiff Prevention, EUDRACT 2008-005244-16
Study First Received: September 8, 2009
Last Updated: April 25, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by National Health Service, United Kingdom:
Clostridium difficile associated diarrhoea
antibiotic associated diarrhoea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms
Signs and Symptoms, Digestive
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014