Prospective randomised controlled study to evaluate the role of synbiotic cocktail 2000 before, during and after liver transplantation to increase resistance to infection
| ISRCTN | ISRCTN73842971 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73842971 |
| Protocol serial number | N0256114034 |
| Sponsor | Department of Health (UK) |
| Funder | The Royal Free Hampstead NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 24/05/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
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 Brian R Davidson
Scientific
Scientific
University Department of Surgery
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Whether giving pre and probiotics could decrease the incidence of infective complications in patients having liver transplantation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Liver transplant |
| Intervention | Prospective randomised controlled trial. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Service outcomes development. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2004 |
| Reason abandoned (if study stopped) | Lack of funding |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 160 |
| Key inclusion criteria | 120 Patients and 40 controls. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 22/07/2002 |
| Date of final enrolment | 01/06/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Department of Surgery
London
NW3 2QG
United Kingdom
NW3 2QG
United Kingdom
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 |
