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
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