Effects of probiotics on liver function in chronic liver disease

ISRCTN ISRCTN50009946
DOI https://doi.org/10.1186/ISRCTN50009946
Secondary identifying numbers 00/207
Submission date
25/10/2009
Registration date
11/11/2009
Last edited
11/11/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
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

Prof Stephen Riordan
Scientific

The Prince of Wales Hospital
Barker Street
Randwick
2031
Australia

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffects of probiotics on liver function in chronic liver disease: a randomised controlled trial
Study objectivesProbiotic treatment may improve liver function in patients with cirrhosis.
Ethics approval(s)South Eastern Illawarra Area Health Service approved on the 5th July 2002 (ref: 00/215)
Health condition(s) or problem(s) studiedCirrhosis
InterventionOral probiotic or placebo therapy for 30 days
Intervention typeOther
Primary outcome measureMarkers of liver function, measured at day 7, day 28 and day 56.
Secondary outcome measuresTolerability, measured at day 7, day 28 and day 56.
Overall study start date01/10/2009
Completion date01/10/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/10/2009
Date of final enrolment01/10/2010

Locations

Countries of recruitment

  • Australia

Study participating centre

The Prince of Wales Hospital
Randwick
2031
Australia

Sponsor information

The Prince of Wales Hospital (Australia)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/022arq532

Funders

Funder type

Other

Investigator initiated and funded (Australia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan