Monitoring the Clinical and Immunological Effects of Microbiome Changes Following Severe Burn Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorTamas Vegh, MD
About this trial
The aim of this study is to longitudinally monitor dynamic changes in the gut microbiome following severe burn injury using fecal samples. Under standard nutritional protocols and intensive care management, serial fecal sampling is performed to assess alterations in microbiome diversity and composition, as well as the indirect effects of these changes on measurable inflammatory biomarkers, endocrine, hematological, immunological, and other organ-specific parameters, the clinical course, and patient outcomes.
Eligibility criteria
Qualifiers
Adult patients (age between 18 and 65 years) meeting the diagnostic criteria for severe burn injury, burns involving more than 20% of the total body surface area (TBSA) and/or inhalation injury.
Burn injury caused by scalding, flame, electrical, contact, or chemical exposure
Hospital admission within 24 hours following injury
Disqualifiers
Patients with inflammatory bowel diseases or malignant neoplasms.
Patients with a history of major gastric and/or intestinal resections
Patients in a pre-injury ECOG performance status of 4.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Tamas Vegh, MD
Lead sponsor
University of Debrecen
Sponsor institution
Source ClinicalTrials.gov