Status:
TERMINATED
Investigation of Thermal Injury on Intestinal Permeability in Both Thermal Injury and Healthy Participants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Burns
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This longitudinal, prospective study aims to establish the magnitude and time course of changes in intestinal permeability; establish the optimal method for assessment of intestinal permeability in th...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- For Healthy participants:
- Males or females must be greater than or equal to 18 years of age at the time of signing informed consent.
- Participants who are healthy as determined by the investigator following medical evaluation including medical history, physical examination, and laboratory tests.
- A female participant is eligible to participate if she is not pregnant (negative pregnancy testing at screening or Day 1 as needed) and not breastfeeding.
- Capable of giving signed informed consent.
- For Thermally injured participants:
- Participants must be greater than or equal to 18 years of age.
- Participants who have sustained a burn (thermal injury) with a Total Burn Surface Area (TBSA) greater than or equal to 15 percent.
- Admission to the burn center (study site) less than or equal to 24 hours following injury.
- Able to take enteral fluids either orally or via a nasogastric tube (depends on facial burn damage).
- A female participant is eligible to participate if she is not pregnant (negative pregnancy testing at study entry) and not breastfeeding.
- Exclusion Criteria
- For Healthy participants:
- Healthy participants are excluded from this study if they are receiving anti-coagulation therapy.
- Pregnancy or breastfeeding.
- A body mass index greater than 34 kilogram per meter square (kg/m\^2).
- An active history of alcohol dependency.
- History of sensitivity to any of the STM, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator and/or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody and confirmatory Hepatitis C Polymerase Chain Reaction (PCR) result within 3 months of screening.
- A positive pre-study urine drug/alcohol screen.
- A positive test for Human Immuno-deficiency Virus (HIV) antibody.
- Participants unable to swallow large capsules (the capsules will be shown to participants at screening).
- Galactosaemia or severe lactose intolerance.
- Use of an antibiotic 2 weeks prior to study start (administration of the STM).
- Gastroenteritis in the 2 weeks prior to study start (administration of the STM).
- For thermally injured participants:
- Chemical or electrical burn.
- Multiple traumatic injuries with an Injury Severity Score (ISS) more than or equal to 16.
- Participants received substantial undocumented management prior to arrival at the study site (burn center) e.g. from paramedics or in a local accident and emergency department.
- Systemic corticoidsteroid use.
- Intravenous (IV) Mannitol use.
- HIV infection.
- Viral Hepatitis B or C infection.
- Gastrointestinal disease (e.g. inflammatory bowel disease) which may affect intestinal permeability.
- Previous bowel resection (e.g. hemicolectomy, small bowel resection).
- Galactosaemia or severe lactose intolerance.
- Bowel obstruction.
- Renal dysfunction requiring renal replacement therapy (end-stage renal failure prior to thermal injury).
- Active autoimmune disease and receiving immunomodulatory therapy e.g. rheumatoid arthritis anti-Tumor Necrosis Factor (TNF).
- Active chemotherapy for cancers or immunoremittive therapies (prednisolone, Adalimumab) within 60 days of thermal injury.
- Premorbid conditions of malignancy currently under treatment.
- Previous bilateral lower extremity amputation.
- Decision not to treat the participant due to futility.
Exclusion
Key Trial Info
Start Date :
January 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03242434
Start Date
January 29 2018
End Date
March 26 2018
Last Update
August 19 2019
Active Locations (1)
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1
GSK Investigational Site
Birmingham, United Kingdom, B15 2TH