Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
07/H0105/71
Study information
Scientific title
Clostridium difficile - adjuvant therapy with high dose VSL#3® will shorten hospital stay and reduce relapse rates in Clostridium difficile associated diarrhoea: a multicentre double blind randomised placebo controlled trial
Acronym
Study hypothesis
The aim of this proposed study is to assess whether high dose VSL#3® (a combined probiotic food supplement) can reduce length of symptoms and length of stay on a Clostridium difficile cohort ward in a district general hospital. The study will also assess any effect of VSL#3® on the incidence of colitis diagnosed in this cohort of patients.
Ethics approval
Ethics approval pending from the London Research Ethics Committee (REC) as of 08/01/2009.
Study design
Double-blind randomised placebo-controlled multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Clostridium difficile associated diarrhoea
Intervention
Adjuvant VSL#3® (probiotic) or placebo, two sachets three times per day, one hour prior to antibiotic therapy.
Total duration of treatment is dependent on the length of symptoms. These usually range from 7 - 14 days but can be longer. Full dose (2 sachets three times a day [tds]) of VSL#3 (probiotic) will be continued until patient is symptom free for 48 hours and then a reduced dose of 2 sachets daily for two weeks following discharge. Therefore the average length of treatment will be one month. Patients will be followed up 4 weeks after resolution of their symptoms to see whether there has been a recurrence.
Intervention type
Drug
Phase
Not Specified
Drug names
VSL#3®
Primary outcome measure
1. Reduction in length of symptoms by 20%, approx expectation is 7 - 10 days
2. Reduction in rates of recurrence of Clostridium difficile associated diarrhoea (CDAD) by 50%, measured within 4 weeks of resolution of symptoms
Secondary outcome measures
1. Reduction in mortality due to primary endpoints mentioned above, measured from admission to one month post resolution of symptoms
2. Reduction in incidence of colitis (colitis diagnosed by abdominal x-ray or computed tomography [CT] and serological markers +/- sigmoidoscopy)
Overall trial start date
01/06/2009
Overall trial end date
01/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Any consenting adult patient over the age of 18 years admitted to a Clostridium difficile Cohort Ward in either Gloucester Royal Hospital or Cheltenham General Hospital. Male and female genders will be included.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
114
Participant exclusion criteria
There is no upper age limit and patients with IBD will not be excluded. Apart from this, the following patients will be excluded:
1. Those with evidence of dilated colon on plain abdominal film on admission
2. Any patient known to be immunosuppressed (including those on steroids)
3. Any patient refusing the VSL#3® as part of their treatment regime
4. Patients with lactose intolerance or allergy
5. Any patient with a history of rheumatic heart disease or prosthetic heart valve
6. Any patient with a history of endocarditis
Recruitment start date
01/06/2009
Recruitment end date
01/06/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
37 Shirehampton Road
Bristol
BS9 1BL
United Kingdom
Sponsor information
Organisation
University Hospitals Bristol NHS Foundation Trust (UK)
Sponsor details
Trust Headquarters
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (UK) - researchers are receiving no financial renumeration for the work on this project
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ferring Pharmaceuticals Ltd (UK) - supplying the VSL#3® and placebo free of charge
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Added 15/09/2008:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NIHR Health Technology Assessment Programme - HTA (UK) - pending
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list