Condition category
Digestive System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
28/04/2015
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 Don Sims

ORCID ID

Contact details

Department of Elderly Medicine
Birmingham Heartlands Hosptial
Bordesley Green Road
Birmingham
B9 5SS
United Kingdom
+44 (0)121 424 2000
donsims@btinternet.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0046153273

Study information

Scientific title

The effect of administration of Lactobacillus casei culture in hospitalised patients who develop diarrhoea

Acronym

Study hypothesis

To reduce the incidence and duration of diarrhoea in elderly patients.

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

Treatment

Patient information sheet

Condition

Diarrhoea

Intervention

Single-centre double-blind randomised controlled trial

Intervention type

Drug

Phase

Not Applicable

Drug names

Lactobacillus casei culture

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2005

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Elderly patients

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

120

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/2005

Recruitment end date

30/06/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Heartlands Hosptial
Birmingham
B9 5SS
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Birmingham Heartlands and Solihull 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