Severely Burned PatientsmicrobiomeNCT07329595
Monitoring the Clinical and Immunological Effects of Microbiome Changes Following Severe Burn Injury
An observational study of Severely Burned Patients and Gut Microbiota Diversity and Composition, run by Tamas Vegh, MD at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severely Burned Patients, Gut Microbiota Diversity and Composition, Inflammatory Responses
- How many people
- 30 participants
- Where
- 1 siteHungary
- Study dates
- 1 Dec 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
University of Debrecen, Department of Anesthesiology and Intensive Care
Debrecen, Hajdú-Bihar, 4032
Lenke Jenei Kluch, MD, +36303884600, jenei.kluch.lenke@med.unideb.hu
Erzsebet Igbonu-Nagy, BSC, +362039915, nagyboske@med.unideb.hu
About this study
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.
Read the 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.
- Conditions
- Severely Burned Patients, Gut Microbiota Diversity and Composition, Inflammatory Responses
- Keywords
- severe burn injury, gut microbiome
- Medical subject headings
- Burns
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of admission, one to two times per week up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Severely Burned PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tamas Vegh, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tamas Vegh, MD, University of Debrecen
- Investigators
- Lenke Jenei Kluch, MD, Principal investigator, University of Debrecen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329595
- Sponsor's protocol ID
- AITT 2023/5
- Other IDs
- RKEB/IKEB 6649/2023, NNGYK/15506-5/2024
- Acronym
- microbiome
- Status last verified
- Jan 2026
- First submitted
- 26 Nov 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nakajima M, Kojiro M, Aso S, Matsui H, Fushimi K, Kaita Y, Goto H, Yamaguchi Y, Yasunaga H. Effect of high-dose vitamin C therapy on severe burn patients: a nationwide cohort study. Crit Care. 2019 Dec 12;23(1):407. doi: 10.1186/s13054-019-2693-1.
PubMed 31831039Song MJ, Kim S, Boo D, Park C, Yoo S, Yoon HI, Cho YJ. Comparison of proton pump inhibitors and histamine 2 receptor antagonists for stress ulcer prophylaxis in the intensive care unit. Sci Rep. 2021 Sep 16;11(1):18467. doi: 10.1038/s41598-021-98069-7.
PubMed 34531488Tanaka H, Matsuda T, Miyagantani Y, Yukioka T, Matsuda H, Shimazaki S. Reduction of resuscitation fluid volumes in severely burned patients using ascorbic acid administration: a randomized, prospective study. Arch Surg. 2000 Mar;135(3):326-31. doi: 10.1001/archsurg.135.3.326.
PubMed 10722036Wischmeyer PE. Nutrition Therapy in Sepsis. Crit Care Clin. 2018 Jan;34(1):107-125. doi: 10.1016/j.ccc.2017.08.008. Epub 2017 Oct 13.
PubMed 29149933Wald EL, Badke CM, Hintz LK, Spewak M, Sanchez-Pinto LN. Vitamin therapy in sepsis. Pediatr Res. 2022 Jan;91(2):328-336. doi: 10.1038/s41390-021-01673-6. Epub 2021 Jul 31.
PubMed 34333556Kahn SA, Beers RJ, Lentz CW. Resuscitation after severe burn injury using high-dose ascorbic acid: a retrospective review. J Burn Care Res. 2011 Jan-Feb;32(1):110-7. doi: 10.1097/BCR.0b013e318204b336.
PubMed 21131846Jeschke MG, Gauglitz GG, Kulp GA, Finnerty CC, Williams FN, Kraft R, Suman OE, Mlcak RP, Herndon DN. Long-term persistance of the pathophysiologic response to severe burn injury. PLoS One. 2011;6(7):e21245. doi: 10.1371/journal.pone.0021245. Epub 2011 Jul 18.
PubMed 21789167Wang Y, Shu Z, Zhu W, Zhou L, Song H, Luo G. The Prognostic Value of N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) in Major Burn Patients With Sepsis. J Burn Care Res. 2022 Nov 2;43(6):1351-1357. doi: 10.1093/jbcr/irac037.
PubMed 35303085Moreno R, Rhodes A, Piquilloud L, Hernandez G, Takala J, Gershengorn HB, Tavares M, Coopersmith CM, Myatra SN, Singer M, Rezende E, Prescott HC, Soares M, Timsit JF, de Lange DW, Jung C, De Waele JJ, Martin GS, Summers C, Azoulay E, Fujii T, McLean AS, Vincent JL. The Sequential Organ Failure Assessment (SOFA) Score: has the time come for an update? Crit Care. 2023 Jan 13;27(1):15. doi: 10.1186/s13054-022-04290-9.
PubMed 36639780McClave SA, Patel J, Bhutiani N. Should fecal microbial transplantation be used in the ICU? Curr Opin Crit Care. 2018 Apr;24(2):105-111. doi: 10.1097/MCC.0000000000000489.
PubMed 29432297van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
PubMed 23323867Fu Y, Moscoso DI, Porter J, Krishnareddy S, Abrams JA, Seres D, Chong DH, Freedberg DE. Relationship Between Dietary Fiber Intake and Short-Chain Fatty Acid-Producing Bacteria During Critical Illness: A Prospective Cohort Study. JPEN J Parenter Enteral Nutr. 2020 Mar;44(3):463-471. doi: 10.1002/jpen.1682. Epub 2019 Aug 6.
PubMed 31385326Schroeder BO, Birchenough GMH, Stahlman M, Arike L, Johansson MEV, Hansson GC, Backhed F. Bifidobacteria or Fiber Protects against Diet-Induced Microbiota-Mediated Colonic Mucus Deterioration. Cell Host Microbe. 2018 Jan 10;23(1):27-40.e7. doi: 10.1016/j.chom.2017.11.004. Epub 2017 Dec 21.
PubMed 29276171He W, Wang Y, Wang P, Wang F. Intestinal barrier dysfunction in severe burn injury. Burns Trauma. 2019 Jul 26;7:24. doi: 10.1186/s41038-019-0162-3. eCollection 2019.
PubMed 31372365Earley ZM, Akhtar S, Green SJ, Naqib A, Khan O, Cannon AR, Hammer AM, Morris NL, Li X, Eberhardt JM, Gamelli RL, Kennedy RH, Choudhry MA. Burn Injury Alters the Intestinal Microbiome and Increases Gut Permeability and Bacterial Translocation. PLoS One. 2015 Jul 8;10(7):e0129996. doi: 10.1371/journal.pone.0129996. eCollection 2015.
PubMed 26154283
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Clinical and Immunological Effects of Microbiome Changes Following Severe Burn Injury
- ClinicalTrials.gov ID
- NCT07329595
- Acronym / sponsor ID
- microbiome / AITT 2023/5
- Conditions
- Severely Burned Patients, Gut Microbiota Diversity and Composition, Inflammatory Responses
- Keywords
- severe burn injury, gut microbiome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tamas Vegh, MDUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Background: PubMed 31831039Nakajima M, Kojiro M, Aso S, Matsui H, Fushimi K, Kaita Y, Goto H, Yamaguchi Y, Yasunaga H. Effect of high-dose vitamin C therapy on severe burn patients: a nationwide cohort study. Crit Care. 2019 Dec 12;23(1):407. doi: 10.1186/s13054-019-2693-1.
- Background: PubMed 34531488Song MJ, Kim S, Boo D, Park C, Yoo S, Yoon HI, Cho YJ. Comparison of proton pump inhibitors and histamine 2 receptor antagonists for stress ulcer prophylaxis in the intensive care unit. Sci Rep. 2021 Sep 16;11(1):18467. doi: 10.1038/s41598-021-98069-7.
- Background: PubMed 10722036Tanaka H, Matsuda T, Miyagantani Y, Yukioka T, Matsuda H, Shimazaki S. Reduction of resuscitation fluid volumes in severely burned patients using ascorbic acid administration: a randomized, prospective study. Arch Surg. 2000 Mar;135(3):326-31. doi: 10.1001/archsurg.135.3.326.
- Background: PubMed 29149933Wischmeyer PE. Nutrition Therapy in Sepsis. Crit Care Clin. 2018 Jan;34(1):107-125. doi: 10.1016/j.ccc.2017.08.008. Epub 2017 Oct 13.
- Background: PubMed 34333556Wald EL, Badke CM, Hintz LK, Spewak M, Sanchez-Pinto LN. Vitamin therapy in sepsis. Pediatr Res. 2022 Jan;91(2):328-336. doi: 10.1038/s41390-021-01673-6. Epub 2021 Jul 31.
- Background: PubMed 21131846Kahn SA, Beers RJ, Lentz CW. Resuscitation after severe burn injury using high-dose ascorbic acid: a retrospective review. J Burn Care Res. 2011 Jan-Feb;32(1):110-7. doi: 10.1097/BCR.0b013e318204b336.
- Background: PubMed 21789167Jeschke MG, Gauglitz GG, Kulp GA, Finnerty CC, Williams FN, Kraft R, Suman OE, Mlcak RP, Herndon DN. Long-term persistance of the pathophysiologic response to severe burn injury. PLoS One. 2011;6(7):e21245. doi: 10.1371/journal.pone.0021245. Epub 2011 Jul 18.
- Background: PubMed 35303085Wang Y, Shu Z, Zhu W, Zhou L, Song H, Luo G. The Prognostic Value of N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) in Major Burn Patients With Sepsis. J Burn Care Res. 2022 Nov 2;43(6):1351-1357. doi: 10.1093/jbcr/irac037.
- Background: PubMed 36639780Moreno R, Rhodes A, Piquilloud L, Hernandez G, Takala J, Gershengorn HB, Tavares M, Coopersmith CM, Myatra SN, Singer M, Rezende E, Prescott HC, Soares M, Timsit JF, de Lange DW, Jung C, De Waele JJ, Martin GS, Summers C, Azoulay E, Fujii T, McLean AS, Vincent JL. The Sequential Organ Failure Assessment (SOFA) Score: has the time come for an update? Crit Care. 2023 Jan 13;27(1):15. doi: 10.1186/s13054-022-04290-9.
- Background: PubMed 29432297McClave SA, Patel J, Bhutiani N. Should fecal microbial transplantation be used in the ICU? Curr Opin Crit Care. 2018 Apr;24(2):105-111. doi: 10.1097/MCC.0000000000000489.
- Background: PubMed 23323867van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
- Background: PubMed 31385326Fu Y, Moscoso DI, Porter J, Krishnareddy S, Abrams JA, Seres D, Chong DH, Freedberg DE. Relationship Between Dietary Fiber Intake and Short-Chain Fatty Acid-Producing Bacteria During Critical Illness: A Prospective Cohort Study. JPEN J Parenter Enteral Nutr. 2020 Mar;44(3):463-471. doi: 10.1002/jpen.1682. Epub 2019 Aug 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lenke Jenei Kluch, MD principal investigator
University of Debrecen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severely Burned Patients and Gut Microbiota Diversity and Composition, run by Tamas Vegh, MD at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lenke Jenei Kluch, MD (+36303884600, jenei.kluch.lenke@med.unideb.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The abundance and bio-diversity of gut microbiota (time frame: Day of admission, one to two times per week up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07329595, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.