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NCT Number: NCT07209007

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

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.

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hallym University Hangang Sacred Heart Hospital

Seoul, 07247, South Korea

Location status: Recruiting

Location contact

Yoon Soo Cho, MD, PhD

CONTACT

[email protected]

+82-2-2639-5730

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

No Intervention: Observational Cohort

Other

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 outcomes

  1. Change in Skin Microbiome Diversity

    Time frame: Baseline, 3, 6, 12, and 24 months after burn injury

    Alpha and beta diversity indices of the skin microbiome will be analyzed using 16S ribosomal RNA (rRNA) gene sequencing and Quantitative Insights Into Microbial Ecology 2 (QIIME2)-based bioinformatics pipeline.

    Unit of Measure: Shannon diversity index (unitless)

  2. Change in Gut Microbiome Diversity

    Time frame: Baseline, 3, 6, 12, and 24 months after burn injury

    Alpha and beta diversity indices of the gut microbiome will be analyzed using 16S ribosomal RNA (rRNA) gene sequencing and Quantitative Insights Into Microbial Ecology 2 (QIIME2)-based bioinformatics pipeline.

    Unit of Measure: Shannon diversity index (unitless)

Secondary outcomes

  1. Functional Prediction of Microbiome

    Time frame: Baseline, 3, 6, 12, 24 months

    Predicted microbial functional pathways will be identified using Phylogenetic Investigation of Communities by Reconstruction of Unobserved States 2 (PICRUSt2) and the Kyoto Encyclopedia of Genes and Genomes (KEGG) database.

    Unit of Measure: Relative pathway abundance (percentage)

  2. Transepidermal Water Loss (TEWL)

    Time frame: Baseline, 3, 6, 12, 24 months

    TEWL will be measured using Tewameter® to assess skin barrier integrity.

    Unit of Measure: grams per square meter per hour (g/m²/h)

  3. Skin Hydration

    Time frame: Baseline, 3, 6, 12, and 24 months after burn injury

    Skin hydration will be measured using Corneometer® to assess stratum corneum moisture levels.

    Unit of Measure: arbitrary units (a.u.)

  4. Skin Elasticity

    Time frame: Baseline, 3, 6, 12, and 24 months after burn injury

    Skin elasticity will be measured using Cutometer® to assess biomechanical recovery of scar tissue.

    Unit of Measure: arbitrary units (a.u.)

  5. Serum C-Reactive Protein (CRP) Concentration

    Time frame: Baseline, 3, 6, 12, 24 months

    Serum CRP concentration will be measured as a systemic inflammatory biomarker.

    Unit of Measure: milligrams per liter (mg/L)

  6. Erythrocyte Sedimentation Rate (ESR)

    Time frame: Baseline, 3, 6, 12, and 24 months after burn injury

    ESR will be measured from peripheral blood samples to assess systemic inflammation.

    Unit of Measure: millimeters per hour (mm/hr)

Study contacts

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

YeonGyun Jung, PhD

CONTACT

[email protected]

+82-2-2639-5730

Yoon Soo Cho, MD, PhD

CONTACT

[email protected]

+82-2-2639-5730

Sponsors and collaborators

Lead sponsor

Cho Yoon soo

Other

Registry information

Official study title

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

Acronym: BURN-MICRO

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Oct 6, 2025
Registry last updated
Oct 6, 2025

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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