Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/02/2006
Date assigned
19/06/2006
Last edited
01/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ken Dunn

ORCID ID

Contact details

Northwest Regional Burns Unit
Acute Block
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 6325
Ken.Dunn@UHSM.NHS.UK

Additional identifiers

EudraCT number

2005-004541-34

ClinicalTrials.gov number

Protocol/serial number

2005-004541-34

Study information

Scientific title

Acronym

Study hypothesis

Provision of an enteral supply of synbiotics to patients with major burns will reduce the high incidence of infections

Ethics approval

Approved by the South Manchester Research Ethics Committee on 12/08/2005, reference number: 05/Q1403/141

Study design

Multicentre randomised double-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

10/03/2006

Overall trial end date

10/03/2009

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

Adults (≥16 years) with ≥15% total body surface area (TBSA) burn
Children (<16 years) with ≥10% TBSA burn

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50+

Participant 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

Recruitment start date

10/03/2006

Recruitment end date

10/03/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northwest Regional Burns Unit
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

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

Sponsor details

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
United Kingdom
+44 (0)161 2915770
Andrew.Maines@manchester.ac.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

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

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

Publication citations

Additional files

Editorial Notes