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
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