Condition category
Infections and Infestations
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
28/08/2015
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 D Knight

ORCID ID

Contact details

Department of Anaesthesia and Intensive Care
Queens Medical Centre
University Hospital
Nottingham
NG7 2UH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192133923

Study information

Scientific title

The effect of probiotic therapy on nosocomial infections in the critically ill

Acronym

Study hypothesis

Does early enteral feeding with probiotics reduce the rate of nosocomial (hospital acquired) infections in the critically ill?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled 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

Infections and Infestations: Nosocomial infections

Intervention

1. Lactobacillus
2. Placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Probiotics

Primary outcome measures

Oropharyngeal nosocomial bacterial carriage rates, nosocomial infection rates, death rates, diarrhoea rates.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

07/10/2003

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

07/10/2003

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Anaesthesia and Intensive Care
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Nottingham University Hospitals NHS Trust (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