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

NCT07329595 | Recruiting DMC

• 3 other identifiers: AITT 2023/5RKEB/IKEB 6649/2023NNGYK/15506-5/2024
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Severely Burned Patients; Gut Microbiota Diversity and Composition; Inflammatory Responses

Keywords

severe burn injury; gut microbiome

Outcome Measures

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.

  Day of admission, one to two times per week up to 12 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tamas Vegh, MD: lead

Study Sites (1)

University of Debrecen, Department of Anesthesiology and Intensive Care

Debrecen, Hajdú-Bihar, 4032, Hungary

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Lenke Jenei Kluch, MD

  University of Debrecen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lenke Jenei Kluch, MD

CONTACT

+36303884600; jenei.kluch.lenke@med.unideb.hu

Erzsebet Igbonu-Nagy, BSC

CONTACT

+36203991551; nagyboske@med.unideb.hu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 9, 2026
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)