The Effect of Enteral Administration of Synbiotics Upon Infection Rates in Major Burns

ISRCTN	ISRCTN16675260
DOI	https://doi.org/10.1186/ISRCTN16675260
EudraCT/CTIS number	2005-004541-34
Secondary identifying numbers	2005-004541-34

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

Northwest Regional Burns Unit
Acute Block
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom

Phone	+44 (0)161 291 6325
Email	Ken.Dunn@UHSM.NHS.UK

Study information

Study design	Multicentre randomised double-blind controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	1. Infection rates (pre-defined definitions) 2. Antibiotic requirements 3. Changes in the microbiological composition of faeces
Secondary outcome measures	1. Mortality rate 2. Nutritional assessment 3. Insulin requirements 4. Assessment of gastrointestinal (GI) function 5. GI side effects 6. Fluid requirements 7. Haematologic and biochemical trends 8. Acute physiology scores 9. Healing times 10. Burn depth progression rates 11. Length of intensive care unit (ICU) and hospital stay 12. Mobilisation times 13. Activities of daily living independence times 14. Post-burns scarring assessment 15. Cost analysis
Overall study start date	10/03/2006
Completion date	10/03/2009
Reason abandoned (if study stopped)	Objectives no longer viable

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Northwest Regional Burns Unit

Manchester
M23 9LT
United Kingdom

Sponsor information

South Manchester University Hospitals NHS Trust (SMUHT) (UK)
Hospital/treatment centre

c/o Dr Andrew Maine
Head of the Research and Development Directorate
Ground Floor
Education and Resource Centre
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
England
United Kingdom

Phone	+44 (0)161 2915770
Email	Andrew.Maines@manchester.ac.uk
"ROR"	https://ror.org/00he80998

Funders

Funder type

Government

South Manchester University Hospitals NHS Trust (SMUHT) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan