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Clostridium difficile - adjuvant therapy with high dose VSL#3® will shorten hospital stay and reduce relapse rates in Clostridium difficile associated diarrhoea
ISRCTN ISRCTN57305201
DOI 10.1186/ISRCTN57305201
ClinicalTrials.gov identifier
EudraCT number
Public title Clostridium difficile - adjuvant therapy with high dose VSL#3® will shorten hospital stay and reduce relapse rates in Clostridium difficile associated diarrhoea
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 N/A
Serial number at source 07/H0105/71
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.

Please note that as of 15/09/2008 this trial has been updated due to a change in the sponsor and a change to the study design (this trial is now multicentre). The title details have also been updated due to the aforementioned change. The initial title details were:
Public title: Adjuvant VSL#3® for the treatment of Clostridium difficile associated diarrhoea
Scientific title: VSL#3® Intervention for the Treatment And Lower Recurrence Rates of Clostridium difficile associated diarrhoea (VITAL-RR): a randomised placebo controlled trial
Acronym: VITAL-RR.
The initial sponsor of this trial was Gloucestershire Hospitals NHS Foundation Trust (UK).

Please note that, as of 12/01/2009, the anticipated start and end dates of this trial have been updated from 01/03/2008 and 01/03/2009 to 01/06/2009 and 01/06/2010, respectively.
Lay summary Not provided at time of registration
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
Countries of recruitment United Kingdom
Disease/condition/study domain Clostridium difficile associated diarrhoea
Participants - 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.
Participants - 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
Anticipated start date 01/06/2009
Anticipated end date 01/06/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 114
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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)
Sources of funding 1. Investigator initiated and funded (UK) - researchers are receiving no financial renumeration for the work on this project
2. Ferring Pharmaceuticals Ltd (UK) - supplying the VSL#3® and placebo free of charge

Added 15/09/2008:
3. NIHR Health Technology Assessment Programme - HTA (UK) - pending
Trial website
Publications
Contact name Dr  Alexandra  di Mambro
  Address 37 Shirehampton Road
Stoke Bishop
  City/town Bristol
  Zip/Postcode BS9 1BL
  Country United Kingdom
Sponsor University Hospitals Bristol NHS Foundation Trust (UK)
  Address Trust Headquarters
Marlborough Street
  City/town Bristol
  Zip/Postcode BS1 3NU
  Country United Kingdom
  Sponsor website: http://www.uhbristol.nhs.uk/
Date applied 20/12/2007
Last edited 22/05/2013
Date ISRCTN assigned 13/02/2008
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