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

Primary Purpose

Diarrhoea

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
VSL#3
Placebo
Sponsored by
National Health Service, United Kingdom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhoea focused on measuring Clostridium difficile associated diarrhoea, antibiotic associated diarrhoea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Royal Albert Edward Infirmary
  • Queen Elizabeth Hospital
  • Frenchay Hospital
  • Hull Royal Infirmary
  • Weston General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

VSL#3

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Development of antibiotic associated diarrhoea
Development of Clostridium difficile associated diarrhoea

Secondary Outcome Measures

Length of Hospital Stay
30-day Mortality

Full Information

First Posted
September 8, 2009
Last Updated
April 25, 2013
Sponsor
National Health Service, United Kingdom
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
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1. Study Identification

Unique Protocol Identification Number
NCT00973908
Brief Title
Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea
Official Title
Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Health Service, United Kingdom
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhoea
Keywords
Clostridium difficile associated diarrhoea, antibiotic associated diarrhoea

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VSL#3
Arm Type
Active Comparator
Arm Description
Patients will receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.
Intervention Type
Drug
Intervention Name(s)
VSL#3
Other Intervention Name(s)
Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus, Streptococcus thermophilus
Intervention Description
Patients will o receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Maltose based Placebo
Intervention Description
Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.
Primary Outcome Measure Information:
Title
Development of antibiotic associated diarrhoea
Time Frame
28 days post last antibiotic dose
Title
Development of Clostridium difficile associated diarrhoea
Time Frame
28 days post last antibiotic dose
Secondary Outcome Measure Information:
Title
Length of Hospital Stay
Time Frame
28 days post last antibiotic dose
Title
30-day Mortality
Time Frame
30 days after initiation of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Haslam
Organizational Affiliation
Wirghtington Wigan and Leigh NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Albert Edward Infirmary
City
Wigan
State/Province
Lancashire
ZIP/Postal Code
WN1 2NN
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Woolwich
State/Province
London
ZIP/Postal Code
SE18 4QH
Country
United Kingdom
Facility Name
Frenchay Hospital
City
Bristol
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Weston General Hospital
City
Weston-super-Mare
ZIP/Postal Code
BS23 4TQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
11118872
Citation
Bergogne-Berezin E. Treatment and prevention of antibiotic associated diarrhea. Int J Antimicrob Agents. 2000 Dec;16(4):521-6. doi: 10.1016/s0924-8579(00)00293-4.
Results Reference
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PubMed Identifier
12052801
Citation
D'Souza AL, Rajkumar C, Cooke J, Bulpitt CJ. Probiotics in prevention of antibiotic associated diarrhoea: meta-analysis. BMJ. 2002 Jun 8;324(7350):1361. doi: 10.1136/bmj.324.7350.1361.
Results Reference
background
PubMed Identifier
12182746
Citation
Cremonini F, Di Caro S, Nista EC, Bartolozzi F, Capelli G, Gasbarrini G, Gasbarrini A. Meta-analysis: the effect of probiotic administration on antibiotic-associated diarrhoea. Aliment Pharmacol Ther. 2002 Aug;16(8):1461-7. doi: 10.1046/j.1365-2036.2002.01318.x.
Results Reference
background
PubMed Identifier
23618760
Citation
Selinger CP, Bell A, Cairns A, Lockett M, Sebastian S, Haslam N. Probiotic VSL#3 prevents antibiotic-associated diarrhoea in a double-blind, randomized, placebo-controlled clinical trial. J Hosp Infect. 2013 Jun;84(2):159-65. doi: 10.1016/j.jhin.2013.02.019. Epub 2013 Apr 22.
Results Reference
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Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea

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