Condition category
Infections and Infestations
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
28/11/2014
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 J S Soothill

ORCID ID

Contact details

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

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

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

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

Publication citations

Additional files

Editorial Notes