Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alexandra di Mambro

ORCID ID

Contact details

37 Shirehampton Road
Stoke Bishop
Bristol
BS9 1BL
United Kingdom

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.

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.

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 measures

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

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

http://www.uhbristol.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Editorial Notes