Monitoring the Clinical and Immunological Effects of Microbiome Changes Following Severe Burn Injury (microbiome)

January 6, 2026 updated by: Tamas Vegh, MD
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hungary
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Recruiting
        • University of Debrecen, Department of Anesthesiology and Intensive Care
        • Sub-Investigator:
          • Ferenc Bodnár, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Irén Erdei, MD
        • Sub-Investigator:
          • Gabriella Emri, MD Full Professor
        • Sub-Investigator:
          • Eszter Janka, MD
        • Sub-Investigator:
          • Gábor Kardos, MD
        • Sub-Investigator:
          • Krisztina Szarka, MD
        • Sub-Investigator:
          • Virág Kardos, medical student
        • Principal Investigator:
          • Lenke Jenei Kluch, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day of admission, one to two times per week up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tamas Vegh, MD

Investigators

  • Principal Investigator: Lenke Jenei Kluch, MD, University of Debrecen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AITT 2023/5
  • RKEB/IKEB 6649/2023 (Registry Identifier: Regional and Institutional Ethics Committee University of Debrecen Clinical Center)
  • NNGYK/15506-5/2024 (Registry Identifier: National Centre for Public Health and Pharmacy)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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