The Effect of Enteral Administration of Synbiotics Upon Infection Rates in Major Burns - The Manchester Synbiotic Study in Major Burns

Phase 1

Active, not recruiting

Conditions: Major burn injuries: Thermal related trauma with burn injury involving significant proportions of the total body surface area, as defined by age:Adults (>=17 years old): >= 15% body surface area involved in burnsChildren (<=16 years old): >=10% body surface area involved in burns

Registration Number: EUCTR2005-004541-34-GB

Lead Sponsor: South Manchester University Healthcare Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

All major burn patients presenting to Manchester Regional Burn Centres:

Adults (>= 17 years) with >= 15% TBSA superficial dermal burn injury (or deeper)

Children (> 12 months & <17 years) with >= 10% TBSA superficial dermal burn injury (or deeper)

ANDAnticipated to have an inpatient admission in excess of 2 weeks.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Injuries that behaving fundamentally differently to thermal burns:
Chemical burns
Electrical burns
Non-burns (e.g. Staphylococcal Scalded Skin Syndrome etc...)
Major non-burn trauma in addition to a major burn injury
Delayed presentation (>12 hours post-injury)
Immunocompromised patients:
Severely immunocompromised
Post-transplant
Altered physiology:
Pregnant patients
Children <1 year old
Patients opting out of the study
Terminally ill, not receiving aggressive treatment
Recently participants in other clinical studies
Gastrointestinal failure, requiring > 24 consecutive hours of TPN as only source of nutrition