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
Protocol serial number	07/H0105/71
Sponsor	University Hospitals Bristol NHS Foundation Trust (UK)
Funders	Investigator initiated and funded (UK) - researchers are receiving no financial renumeration for the work on this project, Ferring Pharmaceuticals Ltd (UK) - supplying the VSL#3® and placebo free of charge, Added 15/09/2008:, NIHR Health Technology Assessment Programme - HTA (UK) - pending

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alexandra di Mambro
Scientific

37 Shirehampton Road
Stoke Bishop
Bristol
BS9 1BL
United Kingdom

Study information

Primary study design	Interventional
Study design	Double-blind randomised placebo-controlled multi-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	VSL#3®
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
Key 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)
Completion date	01/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

37 Shirehampton Road

Bristol
BS9 1BL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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).