Tracking gut microbiome changes after severe burns
Official title: Monitoring the Clinical and Immunological Effects of Microbiome Changes Following Severe Burn Injury
Run by University of Debrecen · NCT07329595 · Data updated 2026-11-12
Researchers will test whether gut microbiome patterns change over time after severe burns and whether those changes relate to inflammation and recovery in adults with major burns.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Debrecen Academic / other |
| Locations | 1 site (Debrecen, Hajdú-Bihar) |
| Status | Recruiting |
| Started | December 1, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | January 9, 2026 |
| Trial ID | NCT07329595 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with severe burns involving >20% total body surface area and/or inhalation injury who are admitted within 24 hours of injury.
✕Probably not a fit
Patients with inflammatory bowel disease, active malignant neoplasms, prior major gastric or intestinal resections, or a pre-injury ECOG performance status of 4 are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adult patients with severe burns admitted within 24 hours will have rectal swabs and serial fecal samples collected one to two times per week while receiving standard ICU nutrition and care. Microbiome diversity and composition will be profiled and correlated with inflammatory biomarkers, endocrine, hematologic, immunologic, and other organ-specific laboratory measures. Clinical outcomes including mortality, length of stay, ventilator duration, secondary infections, bacteremia, SOFA scores, and wound healing will be recorded to link microbial shifts with patient course. The protocol is observational and does not change routine clinical management.
Why it matters
Potential benefit: If successful, the work could identify microbiome signatures that predict complications or recovery after severe burns and inform future prevention or treatment strategies.
How similar studies have gone: Previous observational studies in critically ill and burn populations have linked microbiome disruption to sepsis and organ failure, but interventions to change outcomes by altering the microbiome remain largely unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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University of Debrecen, Department of Anesthesiology and Intensive Care
Debrecen, Hajdú-Bihar, Hungary Recruiting
Study contacts
- Principal investigator: Lenke Jenei Kluch, MD — University of Debrecen
- Study coordinator: Lenke Jenei Kluch, MD
- Email: jenei.kluch.lenke@med.unideb.hu
- Phone: +36303884600
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.