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

NCT07209007 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2025-10-06

No results posted yet for this study

Summary

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.

Conditions

  • Burn Injuries
  • Skin Disease
  • Microbiome
  • Microbiome Dysbiosis

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.

Sponsors & Collaborators

  • Cho Yoon soo

    lead OTHER

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-12-31
Completion
2030-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07209007 on ClinicalTrials.gov