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 | https://doi.org/10.1186/ISRCTN57305201 |
| Secondary identifying numbers | 07/H0105/71 |
- Submission date
- 20/12/2007
- Registration date
- 13/02/2008
- Last edited
- 14/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
37 Shirehampton Road
Stoke Bishop
Bristol
BS9 1BL
United Kingdom
Study information
| Study design | Double-blind randomised placebo-controlled multi-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Ethics approval pending from the London Research Ethics Committee (REC) as of 08/01/2009. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/06/2009 |
| Completion date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 114 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 01/06/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
BS9 1BL
United Kingdom
Sponsor information
Hospital/treatment centre
Trust Headquarters
Marlborough Street
Bristol
BS1 3NU
England
United Kingdom
| Website | http://www.uhbristol.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/04nm1cv11 |
Funders
Funder type
Other
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
14/06/2016: No publications found, verifying study status with principal investigator.
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.
15/09/2008: The 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).
