Actively Recruiting

Age: 19Years - 65Years
All Genders
ID07209007

An Exploratory Study on the Dynamics of Microbiome Dysbiosis in the Skin and Gut Microbiome of Burn Patients

Led by Cho Yoon soo · Updated on 2025-10-06

600

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how the skin and gut microbiomes change over time in adults who have suffered burn injuries compared to healthy individuals. The study focuses on understanding microbial imbalances that may occur not only at burn sites but also on non-burned skin and the gut. This observational cohort study aims to explore the links between these microbiome changes, skin-barrier recovery, and systemic immune responses, enrolling 660 participants including 600 burn patients and 60 healthy controls. Burn patients will provide skin swabs from both burned scars and matched non-burned skin, stool samples, and undergo skin physiological measurements at five time points: baseline (within 7 days after hospital admission), 3 months, 6 months, 12 months, and 24 months after injury. Healthy controls will provide skin and stool samples only once at baseline. Sample analysis includes 16S ribosomal RNA gene sequencing for microbial profiling and functional prediction using PICRUSt2. Blood tests for inflammatory markers such as C-reactive protein and erythrocyte sedimentation rate will also be conducted. Participants will undergo assessments including transepidermal water loss, skin hydration, pH, erythema, and elasticity using standardized instruments at each time point. The study will monitor changes in skin and gut microbiome diversity and function, as well as skin barrier health and systemic inflammation over two years. These comprehensive evaluations aim to provide insights into burn-related microbial changes and their impact on recovery, potentially guiding future therapeutic strategies in long-term burn care.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 19Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - 24 months

Participants provide skin swabs, stool samples, blood samples, and skin physiological measurements to observe changes in the skin and gut microbiome and assess skin barrier recovery and systemic inflammation over time.

5 visits at baseline, 3, 6, 12, and 24 months after burn injury

Trial Site Locations

Total: 1 location

1

Hallym University Hangang Sacred Heart Hospital

Seoul, South Korea, 07247

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Research Team

Y

Yoon Soo Cho, MD, PhD

Y

YeonGyun Jung, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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The skin microbiome of wound scars and unaffected skin in patients with moderate to severe burns in the subacute phase.

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https://pubmed.ncbi.nlm.nih.gov/29663582