Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT03242434
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03242434
Study Brief:
Protocol Section:
NCT03242434