| Source of record | UK Trials |
| ISRCTN | ISRCTN57305201 |
| Date ISRCTN assigned | 13/02/2008 |
| Local reference number(s) | 07/H0105/71 |
| 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 |
| Disease/condition/study domain | Clostridium difficile associated diarrhoea |
| 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. |
| Design/methodology | Single centre, double blind, randomised, placebo controlled trial |
| Research ethics review | Ethics approval pending from the London Research Ethics Committee (REC); application submission date: 28th December 2007, ethics review meeting: 30th January 2008. |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/03/2008 |
| Anticipated end date | 01/03/2009 |
| Status of trial | Ongoing |
| 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 |
| Sponsor name | Gloucestershire Hospitals NHS Foundation Trust (UK) |
| Sponsor details | c/o Mr Mark Walker
1 College Lawn
Cheltenham
United Kingdom
GL53 7AG |
| Sponsor telephone | +44 (0)8454 222222 |
| Sponsor fax | +44 (0)8454 221214 |
| Sponsor email | mark.walker@glos.nhs.uk |
| Sponsor website | http://www.gloshospitals.org.uk/ |
| Contact name | Dr Alexandra di Mambro |
| Contact details | 37 Shirehampton Road
Stoke Bishop
Bristol
United Kingdom
BS9 1BL |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN57305201 |
| Date last extracted from ISRCTN register | 17/04/2008 |
