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NCT Number: NCT07329595

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Debrecen, Department of Anesthesiology and Intensive Care

Debrecen, Hajdú-Bihar, 4032, Hungary

Location status: Recruiting

Location contact

Erzsebet Igbonu-Nagy, BSC

CONTACT

[email protected]

+362039915

Eszter Janka, MD

SUB_INVESTIGATOR

Ferenc Bodnár, MD

SUB_INVESTIGATOR

Gabriella Emri, MD Full Professor

SUB_INVESTIGATOR

Gábor Kardos, MD

SUB_INVESTIGATOR

Irén Erdei, MD

SUB_INVESTIGATOR

Krisztina Szarka, MD

SUB_INVESTIGATOR

Lenke Jenei Kluch, MD

CONTACT

[email protected]

+36303884600

Lenke Jenei Kluch, MD

PRINCIPAL_INVESTIGATOR

Virág Kardos, medical student

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erzsebet Igbonu-Nagy, BSC

CONTACT

[email protected]

+36203991551

Lenke Jenei Kluch, MD

CONTACT

[email protected]

+36303884600

Sponsors and collaborators

Lead sponsor

Tamas Vegh, MD

Other

Registry information

Acronym: microbiome

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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