Condition category
Digestive System
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
01/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christian Selinger

ORCID ID

Contact details

Wrightington
Wigan and Leigh NHS Foundation Trust
Endoscopy Unit
Wigan Lane
Wigan
WN1 2NN
United Kingdom
christian.selinger@web.de

Additional identifiers

EudraCT number

2008-005244-16

ClinicalTrials.gov number

NCT00973908

Protocol/serial number

8157

Study information

Scientific title

Probiotics for the prevention of antibiotic associated diarrhoea and Clostridium difficile associated diarrhoea: a multicentre randomised interventional phase II prevention trial

Acronym

Study hypothesis

The study aims to establish whether VSL#3 compared to placebo prevents antibiotic-associated diarrhoea and Clostridium difficile associated diarrhoea in hospitalised patients on systemic antibiotics.

Ethics approval

North Staffordshire Local Research Ethics Committee 3 approved on the 22nd April 2010 (ref: 08/H1201/147)

Study design

Multicentre randomised interventional phase II prevention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Gastrointestinal

Intervention

Intervention: 1 sachet of VSL#3 twice daily for the duration of the antibiotic course and seven days thereafter.
Control: 1 sachet of placebo twice daily for the duration of the antibiotic cource and seven days thereafter.

Follow-up until 28 days after the last antibiotic dose.
Study entry: single randomisation only

Intervention type

Drug

Phase

Phase II

Drug names

VSL#3

Primary outcome measures

Development of CDAD, measured at 28 days after last antibiotic dose

Secondary outcome measures

1. 30 day mortality
2. Development of AAD, measured at 28 days post-last antibiotic dose
3. Length of hospital stay

Overall trial start date

01/04/2010

Overall trial end date

10/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Systemic antibiotics
2. Aged 18 years or older, either sex
3. Able to take enteral medication (sachets)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 445; UK sample size: 445

Participant exclusion criteria

1. Diarrhoea at screening
2. Unable to take enteral medication
3. Patients on intensive care units
4. Severe immunosuppression (neutropenia, acquired immunodeficiency syndrome [AIDS], congenital immunoparesis, chemotherapy)
5. Risk of endocarditis (artificial heart valves, history of rheumatic heart disease or infective endocarditis)
6. Regular consumption of probiotics until 1 week prior to admission
7. Acute severe pancreatitis
8. Persistent vomiting (two days or more)

Recruitment start date

01/04/2010

Recruitment end date

10/03/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan
WN1 2NN
United Kingdom

Sponsor information

Organisation

Wrightington, Wigan and Leigh NHS Foundation Trust (UK)

Sponsor details

Clinical Trials Unit
Hall Lane
Appley Bridge
Wigan
WN6 9EP
United Kingdom

Sponsor type

Government

Website

http://www.wiganleigh.nhs.uk

Funders

Funder type

Industry

Funder name

Ferring Pharmaceuticals Ltd (UK)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23618760

Publication citations

  1. Results

    Selinger CP, Bell A, Cairns A, Lockett M, Sebastian S, Haslam N, Probiotic VSL#3 prevents antibiotic-associated diarrhoea in a double-blind, randomized, placebo-controlled clinical trial., J. Hosp. Infect., 2013, 84, 2, 159-165, doi: 10.1016/j.jhin.2013.02.019.

Additional files

Editorial Notes