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
This trial does not accept healthy volunteersQualifiers
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 population
Thirty adult patients (age between 18 and 65 year) 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
The abundance and bio-diversity of gut microbiota
Genomic DNA is extracted from the collected samples, followed by PCR amplification of the eubacterial 16S rRNA gene. The amplified region is subsequently sequenced, and taxonomic assignment is performed based on sequence analysis. Following the calculation of relative taxonomic abundances, alpha and beta diversity metrics are compared across longitudinal samples within individual patients and between patients.
Time frame
Day of admission, one to two times per week up to 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tamas Vegh, MD
Lead sponsor
University of Debrecen
Sponsor institution
Source ClinicalTrials.gov