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

Recruiting now

Conditions studied: Burn Injuries, Skin Disease, Microbiome, Microbiome Dysbiosis

In brief

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.

Key facts

Study ID

NCT07209007

Run by

Cho Yoon soo

People needed

600

Starts

2025-09-15

Expected to finish

2030-12-31

Last updated by the study team

2025-10-06

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hallym University Hangang Sacred Heart Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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