Effects of probiotics on liver function in chronic liver disease
| ISRCTN | ISRCTN50009946 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50009946 |
| Protocol serial number | 00/207 |
| Sponsor | The Prince of Wales Hospital (Australia) |
| Funder | Investigator initiated and funded (Australia) |
- 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
Scientific
The Prince of Wales Hospital
Barker Street
Randwick
2031
Australia
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of probiotics on liver function in chronic liver disease: a randomised controlled trial |
| Study objectives | Probiotic 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) studied | Cirrhosis |
| Intervention | Oral probiotic or placebo therapy for 30 days |
| Intervention type | Other |
| Primary outcome measure(s) |
Markers of liver function, measured at day 7, day 28 and day 56. |
| Key secondary outcome measure(s) |
Tolerability, measured at day 7, day 28 and day 56. |
| Completion date | 01/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2009 |
| Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- Australia
Study participating centre
The Prince of Wales Hospital
Randwick
2031
Australia
2031
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
