Investigation of Themal Injury and Intestinal Permeability
Research type
Research Study
Full title
A Prospective, Longitudinal Study to Investigate the Effect of Thermal Injury on Intestinal Permeability and Systemic Inflammation (HESTIA)
IRAS ID
223886
Contact name
Naeim Moiemen
Contact email
Sponsor organisation
GlaxoSmithKline
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 12 days
Research summary
This study, sponsored by GSK, is comparing the permeability of the gut of healthy volunteers compared to patients with thermal burns. No drug will be used for this study. Instead we will be using a sugar solution of lactulose, mannitol and sucralose which will be ingested and measured upon excretion from the body (within the urine). These sugars are not normally able to pass through the gut wall in healthy subjects but are predicted to be able to in thermal burn patients, thus providing a clear picture of how thermal burns immediately impact gut permeability, and how this is affected over time. We aim to be able to design future studies by comparing the results of sugar levels leaving the body from healthy volunteers and the burn patients.
The study will utilize adult burn patients and adult healthy volunteers. Specialized burn centres and designated phase 1 units will be used for the recruitment and running of this study. Healthy volunteers will be on study for a maximum of two weeks attending a total of 4 visits whilst burn patients will be in the study for 6 months with 15 visits in total. The earlier portion of these visits for burn patients will be held alongside the inpatient care being provided for the recent burn injury. The following tests will be performed over the different visits: physical examination, urine, stool and blood samples (for screening only).
It is a UK only study which will aim to enrol 25 patients with thermal burns and 15 healthy volunteers.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
17/LO/1070
Date of REC Opinion
10 Oct 2017
REC opinion
Further Information Favourable Opinion