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?

ISRCTN ISRCTN26317136
DOI https://doi.org/10.1186/ISRCTN26317136
Protocol serial number N0012128241
Sponsor Department of Health
Funders Great Ormond Street Hospital for Children, Institute of Child Health, University College London
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
28/11/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J S Soothill
Scientific

Microbiology
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleA 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?
Study objectivesTo investigate whether administration of a probiotic preparation reduces the carriage of Enterobacteriaceae in the gut.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedInfections and Infestations: Gram-negative bacteriae
Intervention1. Probiotics - treatment for gut infection
2. No treatment
Intervention typeOther
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/11/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Key inclusion criteriaHealthy adult volunteers
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/03/2002
Date of final enrolment30/11/2005

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Great Ormond Street Hospital
London
WC1N 3JH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan