Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0012128241
Study information
Scientific title
A study to investigate the effect of probiotics on faecal flora - does administration of the probiotic 'Acidophilus' reduce counts of Enterobacteriaceae in the intestines of healthy volunteers?
Acronym
Study hypothesis
To investigate whether administration of a probiotic preparation reduces the carriage of Enterobacteriaceae in the gut.
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
Not specified
Trial type
Other
Patient information sheet
Condition
Infections and Infestations: Gram-negative bacteriae
Intervention
1. Probiotics - treatment for gut infection
2. No treatment
Intervention type
Other
Phase
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2002
Overall trial end date
30/11/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy adult volunteers
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2002
Recruitment end date
30/11/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Great Ormond Street Hospital
London
WC1N 3JH
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
Government
Funder name
Great Ormond Street Hospital for Children
Alternative name(s)
GOSH
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Funder name
Institute of Child Health, University College London
Alternative name(s)
ICH
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
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