Condition category
Digestive System
Date applied
25/10/2009
Date assigned
11/11/2009
Last edited
11/11/2009
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

Prof Stephen Riordan

ORCID ID

Contact details

The Prince of Wales Hospital
Barker Street
Randwick
2031
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

00/207

Study information

Scientific title

Effects of probiotics on liver function in chronic liver disease: a randomised controlled trial

Acronym

Study hypothesis

Probiotic treatment may improve liver function in patients with cirrhosis.

Ethics approval

South Eastern Illawarra Area Health Service approved on the 5th July 2002 (ref: 00/215)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cirrhosis

Intervention

Oral probiotic or placebo therapy for 30 days

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Markers of liver function, measured at day 7, day 28 and day 56.

Secondary outcome measures

Tolerability, measured at day 7, day 28 and day 56.

Overall trial start date

01/10/2009

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged between 18 and 70 years (either sex) with established cirrhosis
2. No antibiotic or lactulose therapy within 6 weeks
3. No prior use of probiotic therapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Age under 18 years or over 70 years
2. Antibiotic or lactulose therapy within 6 weeks
3. Prior use of probiotic therapy
4. Hepatocellular carcinoma

Recruitment start date

01/10/2009

Recruitment end date

01/10/2010

Locations

Countries of recruitment

Australia

Trial participating centre

The Prince of Wales Hospital
Randwick
2031
Australia

Sponsor information

Organisation

The Prince of Wales Hospital (Australia)

Sponsor details

c/o Professor Stephen Riordan
Blacket Building
Barker Street
Randwick
2031
Australia

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Australia)

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