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Recruiting NCT07209007

Dynamics of Dysbiosis in the Skin and Gut Microbiome of Burn Patients

— Observational Burn Injuries Skin Disease Microbiome Microbiome Dysbiosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention: Observational Cohort.
Who it may be relevant to
Registry conditions: Burn Injuries, Skin Disease, Microbiome, Microbiome Dysbiosis. Basic parameters: 19 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Exploratory Study on the Dynamics of Microbiome Dysbiosis (Microbial Imbalance) in the Skin and Gut Microbiome of Burn Patients

Overview

This prospective observational cohort study aims to investigate the longitudinal changes in the skin and gut microbiome of burn patients after injury and compare them with healthy controls. Burn injuries are known to induce systemic physiological and immune responses that may lead to widespread microbial dysbiosis (microbial imbalance) beyond the injured site. However, the dynamics of microbial community changes in both burned and non-burned skin, as well as the gut, remain poorly understood. In this study, a total of 660 participants will be enrolled, including 600 burn patients and 60 healthy controls. For burn patients, skin swabs from burned scars and matched non-burned skin, stool samples, and physiological skin measurements will be collected at multiple time points (baseline, 3 months, 6 months, 12 months, and 24 months). Healthy controls will provide skin and stool samples at baseline only. Microbial profiling will be performed using 16S ribosomal RNA (rRNA) gene sequencing, and functional prediction will be analyzed using Phylogenetic Investigation of Communities by Reconstruction of Unobserved States 2 (PICRUSt2). Physiological skin-barrier measurements, including transepidermal water loss (TEWL), hydration, pH, erythema, and elasticity, will be assessed using standardized instruments. Blood biomarkers, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), will also be measured. The findings of this study will improve our understanding of burn-related microbial dysbiosis, provide insights into microbiome-driven skin-barrier recovery, and inform potential therapeutic strategies for long-term burn care.

Detailed description

This is a prospective, observational cohort study conducted at the Burn Institute of Hallym University Hangang Sacred Heart Hospital. The study aims to characterize temporal changes in the skin and gut microbiome of burn patients compared with healthy controls and to identify potential links between microbiome dynamics, skin-barrier recovery, and systemic immune responses.

A total of 660 participants will be enrolled, including 600 burn patients and 60 healthy controls. Burn patients will be followed longitudinally for 24 months, with sample collection and clinical measurements performed at baseline (within 7 days after hospital admission), 3 months, 6 months, 12 months, and 24 months after injury. Healthy controls will provide single-timepoint samples for comparison.

Sample Collection Skin Microbiome: Swabs will be collected from burned scars and matched non-burned skin sites.

Gut Microbiome: Stool samples will be collected for 16S ribosomal RNA (rRNA) gene sequencing.

Skin Physiological Measurements: Transepidermal water loss (TEWL), hydration, erythema, melanin index, elasticity, and pH levels will be measured using standardized instruments (Corneometer®, Tewameter®, Mexameter®, Cutometer®, and pH meter).

Blood Biomarkers: Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), interleukin-6 (IL-6), and other systemic inflammatory markers will be analyzed.

Microbiome Profiling DNA extraction and 16S rRNA gene sequencing will be performed using Illumina sequencing platforms. Bioinformatic processing will be conducted using the Quantitative Insights Into Microbial Ecology 2 (QIIME2) pipeline. Functional prediction of microbial metabolic pathways will be analyzed with Phylogenetic Investigation of Communities by Reconstruction of Unobserved States 2 (PICRUSt2). Beta diversity and alpha diversity indices will be calculated, and taxonomic differences between groups will be assessed using Linear Discriminant Analysis Effect Size (LEfSe).

Clinical Relevance Microbiome dysbiosis (microbial imbalance) after burn injury may extend beyond local wounds and affect non-burned skin and the gut, contributing to impaired skin-barrier function, immune dysregulation, and delayed recovery. Understanding these relationships may help develop microbiome-targeted therapeutic interventions, improve wound healing, and optimize long-term patient care.

Interventions

  • Other No Intervention: Observational Cohort
    This is an observational cohort study with no interventions administered. Skin swabs, stool samples, blood samples, and skin physiological measurements will be collected at baseline, 3, 6, 12, and 24 months after burn injury to investigate longitudinal changes in the skin and gut microbiome.

Primary outcome measures

  • Change in Skin Microbiome Diversity [Time frame: Baseline, 3, 6, 12, and 24 months after burn injury]
  • Change in Gut Microbiome Diversity [Time frame: Baseline, 3, 6, 12, and 24 months after burn injury]
Secondary outcome measures (6)
  • Functional Prediction of Microbiome [Time frame: Baseline, 3, 6, 12, 24 months]
  • Transepidermal Water Loss (TEWL) [Time frame: Baseline, 3, 6, 12, 24 months]
  • Skin Hydration [Time frame: Baseline, 3, 6, 12, and 24 months after burn injury]
  • Skin Elasticity [Time frame: Baseline, 3, 6, 12, and 24 months after burn injury]
  • Serum C-Reactive Protein (CRP) Concentration [Time frame: Baseline, 3, 6, 12, 24 months]
  • Erythrocyte Sedimentation Rate (ESR) [Time frame: Baseline, 3, 6, 12, and 24 months after burn injury]

Eligibility criteria

Inclusion criteria

  • Adults aged 19 to 65 years
  • Patients with partial- or full-thickness burns whose wounds have completely healed following debridement, grafting, or conservative treatment
  • Ability to understand study objectives and provide written informed consent

Exclusion criteria

  • Use of systemic or topical antibiotics, probiotics, steroids, or immunosuppressants within 2 weeks prior to sample collection
  • Pregnancy or breastfeeding
  • Chronic skin diseases (e.g., psoriasis, eczema) or systemic illnesses affecting the skin microbiome
  • Active infections at the sampling site
  • Any medical condition judged by the investigator to make participation inappropriate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Hallym University Hangang Sacred Heart Hospital — Seoul

Publications

  • Jung Y, Cui HS, Joo SY, Lee EK, Seo CH, Cho YS. Sex differences in the skin microbiome of burn scars. Wound Repair Regen. 2023 Jul-Aug;31(4):547-558. doi: 10.1111/wrr.13088. Epub 2023 Jun 24. PMID 37129034
  • Jung Y, Cui HS, Lee EK, Joo SY, Seo CH, Cho YS. Effects of Factors Influencing Scar Formation on the Scar Microbiome in Patients with Burns. Int J Mol Sci. 2023 Nov 6;24(21):15991. doi: 10.3390/ijms242115991. PMID 37958976
  • Ersanli C, Tzora A, Voidarou CC, Skoufos S, Zeugolis DI, Skoufos I. Biodiversity of Skin Microbiota as an Important Biomarker for Wound Healing. Biology (Basel). 2023 Aug 30;12(9):1187. doi: 10.3390/biology12091187. PMID 37759587
  • Corcione S, Lupia T, De Rosa FG; Host and Microbiota Interaction Study Group (ESGHAMI) of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). Microbiome in the setting of burn patients: implications for infections and clinical outcomes. Burns Trauma. 2020 Aug 14;8:tkaa033. doi: 10.1093/burnst/tkaa033. eCollection 2020. PMID 32821744
  • Nakai K, Kubota Y, Soma GI, Kohchi C. The Effect of Lipopolysaccharide-containing Moisturizing Cream on Skin Care in Patients With Mild Atopic Dermatitis. In Vivo. 2019 Jan-Feb;33(1):109-114. doi: 10.21873/invivo.11446. PMID 30587610
  • Ogawa R, Akaishi S. Endothelial dysfunction may play a key role in keloid and hypertrophic scar pathogenesis - Keloids and hypertrophic scars may be vascular disorders. Med Hypotheses. 2016 Nov;96:51-60. doi: 10.1016/j.mehy.2016.09.024. Epub 2016 Sep 28. PMID 27959277
  • Gimblet C, Meisel JS, Loesche MA, Cole SD, Horwinski J, Novais FO, Misic AM, Bradley CW, Beiting DP, Rankin SC, Carvalho LP, Carvalho EM, Scott P, Grice EA. Cutaneous Leishmaniasis Induces a Transmissible Dysbiotic Skin Microbiota that Promotes Skin Inflammation. Cell Host Microbe. 2017 Jul 12;22(1):13-24.e4. doi: 10.1016/j.chom.2017.06.006. Epub 2017 Jun 29. PMID 28669672
  • Liu SH, Huang YC, Chen LY, Yu SC, Yu HY, Chuang SS. The skin microbiome of wound scars and unaffected skin in patients with moderate to severe burns in the subacute phase. Wound Repair Regen. 2018 Mar;26(2):182-191. doi: 10.1111/wrr.12632. Epub 2018 May 21. PMID 29663582

Identifiers

NCT: NCT07209007 · HG 2025-023 · HG2025-023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗