An Exploratory Study on the Dynamics of Microbiome Dysbiosis (Microbial Imbalance) in the Skin and Gut Microbiome of Burn Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Change in Skin Microbiome Diversity
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Skin Microbiome Diversity
时间窗: 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)
Change in Gut Microbiome Diversity
时间窗: 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)
次要结局
- Skin Elasticity(Baseline, 3, 6, 12, and 24 months after burn injury)
- Serum C-Reactive Protein (CRP) Concentration(Baseline, 3, 6, 12, 24 months)
- Erythrocyte Sedimentation Rate (ESR)(Baseline, 3, 6, 12, and 24 months after burn injury)
- Functional Prediction of Microbiome(Baseline, 3, 6, 12, 24 months)
- Transepidermal Water Loss (TEWL)(Baseline, 3, 6, 12, 24 months)
- Skin Hydration(Baseline, 3, 6, 12, and 24 months after burn injury)
研究者
Cho Yoon soo
Professor
Hangang Sacred Heart Hospital
