The Effect of Enteral Administration of Synbiotics Upon Infection Rates in Major Burns
| ISRCTN | ISRCTN16675260 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16675260 |
| Clinical Trials Information System (CTIS) | 2005-004541-34 |
| Protocol serial number | 2005-004541-34 |
| Sponsor | South Manchester University Hospitals NHS Trust (SMUHT) (UK) |
| Funder | South Manchester University Hospitals NHS Trust (SMUHT) (UK) |
- Submission date
- 23/02/2006
- Registration date
- 19/06/2006
- Last edited
- 01/06/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Injury, Occupational Diseases, Poisoning
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
Mr Ken Dunn
Scientific
Scientific
Northwest Regional Burns Unit
Acute Block
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 291 6325 |
|---|---|
| Ken.Dunn@UHSM.NHS.UK |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised double-blind controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Provision of an enteral supply of synbiotics to patients with major burns will reduce the high incidence of infections |
| Ethics approval(s) | Approved by the South Manchester Research Ethics Committee on 12/08/2005, reference number: 05/Q1403/141 |
| Health condition(s) or problem(s) studied | Major burn injury |
| Intervention | Two equal randomised groups, investigational medicinal product (IMP) group will be given a synbiotic cocktail comprising 10^11 of each of 4 probiotic strains and 4 prebiotics. The control group will be given only the 4 prebiotics. The IMP and control will be identically packaged and will be administered twice daily throughout the inpatient admission by either oral or gastroenteral administration. Added 01/06/10: trial stopped in 2006 (objectives no longer viable). |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Infection rates (pre-defined definitions) |
| Key secondary outcome measure(s) |
1. Mortality rate |
| Completion date | 10/03/2009 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | Adults (≥16 years) with ≥15% total body surface area (TBSA) burn Children (<16 years) with ≥10% TBSA burn |
| Key exclusion criteria | 1. Patients sustaining injuries that behave fundamentally differently to thermal burns (chemical burns, electrical burns and non-burns (e.g. staphylococcal scalded skin syndrome etc.) 2. Major non-burn trauma in addition to a major burn injury 3. Patients whose presentation is delayed >12 hours post-injury 4. Severely immunocompromised 5. Post-transplant patients 6. Altered physiology (pregnant patients, children <1 year old) 7. Patients opting out of the study 8. Terminally ill, not receiving aggressive treatment 9. Patients who have recently participated or are participating in other clinical studies will be evaluated on a case by case basis to evaluate the risk to the patient, and any bias, which may be introduced to either study 10. Patients with gastrointestinal failure, requiring >24 consecutive hours of total parenteral nutrition |
| Date of first enrolment | 10/03/2006 |
| Date of final enrolment | 10/03/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Northwest Regional Burns Unit
Manchester
M23 9LT
United Kingdom
M23 9LT
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 |
