Condition category
Digestive System
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
30/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lindsay Parker

ORCID ID

Contact details

Aintree University Hospitals
Fazakerley Hospital
Lower Lane
Liverpool
L9 7AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7425

Study information

Scientific title

Use of probiotic yoghurt to prevent diarrhoea in critical care: A randomised double-blind, placebo-controlled trial

Acronym

Study hypothesis

Do probiotics reduce the incidence of diarrhoea in critically ill patients taking antibiotics?

Ethics approval

MREC, ref: 08/H1003/95

Study design

Single-centre randomised interventional prevention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Public Health Research

Intervention

Patients will be randomised to receive either one sachet of VSL#3 or placebo twice daily via their nasogastric tube, or feeding gastrostomy/jejunostomy. Probiotic/placebo administration will continue for the duration of antibiotic therapy and for a further 7 days following cessation of antibiotics.

Intervention type

Other

Phase

Phase I

Drug names

Primary outcome measures

Diarrhoea: defined as more than 3 loose stools per day (Bristol stool chart grade 7)

Secondary outcome measures

Clostridium difficile associated disease: Clostridium difficile A or B toxin (CDT) positive stool sample

Overall trial start date

01/10/2008

Overall trial end date

01/10/2010

Reason abandoned

Lack of staff/facilities/resources

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Planned sample size: 192

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2008

Recruitment end date

01/10/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Aintree University Hospitals
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

Aintree University Hospitals NHS Foundation Trust (UK)

Sponsor details

Fazakerley Hospital
Lower Lane
Liverpool
L9 7AL
United Kingdom

Sponsor type

Government

Website

http://www.aintreehospitals.nhs.uk

Funders

Funder type

Charity

Funder name

Hospital Infection Society (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute of Academic Anaesthesia (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

Publication citations

Additional files

Editorial Notes

30/08/2016: this trial did not start because of difficulties getting a supply of the trial product.