---
title: Monitoring the Clinical and Immunological Effects of Microbiome Changes Following Severe Burn Injury
nct_id: NCT07329595
overall_status: RECRUITING
sponsor: Tamas Vegh, MD
study_type: OBSERVATIONAL
primary_condition: Severely Burned Patients
countries: Hungary
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07329595.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07329595"
ct_last_update_post_date: 2026-01-09
last_seen_at: "2026-05-12T06:26:53.314Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Monitoring the Clinical and Immunological Effects of Microbiome Changes Following Severe Burn Injury

**NCT ID:** [NCT07329595](https://clinicaltrials.gov/study/NCT07329595)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Tamas Vegh, MD
- **Conditions:** Severely Burned Patients, Gut Microbiota Diversity and Composition, Inflammatory Responses
- **Start Date:** 2023-12-01
- **Completion Date:** 2026-12-31
- **CT.gov Last Update:** 2026-01-09

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
```

## Primary Outcomes

- **The abundance and bio-diversity of gut microbiota** _(time frame: Day of admission, one to two times per week up to 12 weeks)_ — 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.

## Locations (1)

- University of Debrecen, Department of Anesthesiology and Intensive Care, Debrecen, Hajdú-Bihar, Hungary — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of debrecen, department of anesthesiology and intensive care|debrecen|hajdú-bihar|hungary` — added _(2026-05-12)_

---

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