Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:56 AM
Study NCT ID:
NCT07329595
Status:
RECRUITING
Last Update Posted:
2026-01-09
First Post:
2025-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring the Clinical and Immunological Effects of Microbiome Changes Following Severe Burn Injury
Sponsor:
Tamas Vegh, MD
Organization:
Study Overview
Official Title:
Monitoring the Clinical and Immunological Effects of Microbiome Changes Following Severe Burn Injury
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
microbiome
Brief Summary:
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.
Detailed Description:
Severe burn injury induces stress-related intestinal damage, leading to decreased gut perfusion, cellular injury, increased mucosal permeability, and reduced intestinal motility. These pathophysiological changes facilitate bacterial and endotoxin translocation, making the gut microbiome a major source of endogenous infection. Recent evidence indicates that the gut microbiome plays a critical role in regulating immune responses and supporting post-injury recovery, while also contributing to the development of complications such as sepsis and multi-organ failure.
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. Clinical outcomes are evaluated based on mortality, length of hospital stay, duration of mechanical ventilation, incidence of secondary infections, rate of bacteremia, organ failure and its severity (assessed using the SOFA score), and wound healing.
Upon enrollment, patients undergo rectal swab collection and initial fecal sampling, followed by weekly fecal sample collection one to two times per week, alongside weekly laboratory investigations in addition to standard care. For microbiome analysis, DNA is extracted from fecal samples, followed by PCR amplification of the 16S bacterial rRNA operon. The amplified regions are sequenced, and taxa are identified based on sequence data. Relative abundances of taxa are calculated, and alpha- and beta-diversity metrics are compared within serial samples from individual patients and between patients.
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. Clinical outcomes are evaluated based on mortality, length of hospital stay, duration of mechanical ventilation, incidence of secondary infections, rate of bacteremia, organ failure and its severity (assessed using the SOFA score), and wound healing.
Upon enrollment, patients undergo rectal swab collection and initial fecal sampling, followed by weekly fecal sample collection one to two times per week, alongside weekly laboratory investigations in addition to standard care. For microbiome analysis, DNA is extracted from fecal samples, followed by PCR amplification of the 16S bacterial rRNA operon. The amplified regions are sequenced, and taxa are identified based on sequence data. Relative abundances of taxa are calculated, and alpha- and beta-diversity metrics are compared within serial samples from individual patients and between patients.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: