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临床试验/NCT07209007
NCT07209007招募中不适用

An Exploratory Study on the Dynamics of Microbiome Dysbiosis (Microbial Imbalance) in the Skin and Gut Microbiome of Burn Patients

Cho Yoon soo1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年9月15日最近更新:
适应症

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

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

发起方
Cho Yoon soo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cho Yoon soo

Professor

Hangang Sacred Heart Hospital

研究点 (1)

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