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

ConditionsBurn InjuriesSkin DiseaseMicrobiomeMicrobiome Dysbiosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-65
SponsorCho Yoon soo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

This study will enroll 600 adult burn patients aged 19 to 65 years who have experienced partial- or full-thickness burns. Participants will be recruited from the Burn Center at Hallym University Hangang Sacred Heart Hospital. All participants must provide written informed consent.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention: Observational Cohort

    Other intervention

    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.

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: Burn Patients Cohort1 intervention

Trial outcomes

Primary outcomes

1

Change in Skin Microbiome Diversity

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)

Time frame
Baseline, 3, 6, 12, and 24 months after burn injury
2

Change in Gut Microbiome Diversity

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)

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

Secondary outcomes

1

Functional Prediction of Microbiome

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)

Time frame
Baseline, 3, 6, 12, 24 months
2

Transepidermal Water Loss (TEWL)

TEWL will be measured using Tewameter® to assess skin barrier integrity. Unit of Measure: grams per square meter per hour (g/m²/h)

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

Skin Hydration

Skin hydration will be measured using Corneometer® to assess stratum corneum moisture levels. Unit of Measure: arbitrary units (a.u.)

Time frame
Baseline, 3, 6, 12, and 24 months after burn injury
4

Skin Elasticity

Skin elasticity will be measured using Cutometer® to assess biomechanical recovery of scar tissue. Unit of Measure: arbitrary units (a.u.)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cho Yoon soo

Lead sponsor

Hangang Sacred Heart Hospital

Sponsor institution

Source ClinicalTrials.gov
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