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临床试验/NCT04781036
NCT04781036进行中(未招募)不适用

The Study of Foot-skin Microbiome and Metabolomics of Thai Naval Cadets With Pitted Keratolysis

Mahidol University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
250
试验地点
1
主要终点
Composition of microbiota at skin

研究概览

简要总结

This study aimed to investigate the skin microbiome and metabolomics of patients with pitted keratolysis.

详细描述

Pitted keratolysis is a skin infectious disease which can cause an unpleasant smell that can affect self-confidence and interpersonal relationships. The research problem was initiated through a community outreach program organized by the Department of Dermatology Siriraj Hospital, Thailand. From many years of experiences, our dermatologist teams observed that pitted keratolysis was a common disease among naval cadets who wore enclosed footwear for long hours, and it was more prevalent after a boot camp that spanned over months. This disease is chronic with no efficient standard treatment and limited information on the pathogenesis of the disease. Therefore, we propose to conduct a study on the pathogenesis of pitted keratolysis and malodorous feet through a longitudinal study of foot-skin microbiome and associated volatile metabolomic profiles of foot odor. With the unique population, with similar age range, daily activities, and diet, this study will allow to focus on the association of changes in microbiome in relation to pathogenesis of pitted keratolysis and malodorous feet, with fewer cofounding factors.

The skin microbiome is a group of various microorganisms, such as bacteria, fungi, and viruses, residing on skin. Human skin microbiome can differ with respect to age, ethnicity, diet, climate and environment. Recently, there have been numerous studies highlighting the association of microbes with pathogenesis of various skin diseases, such as atopic dermatitis, acne vulgaris, and psoriasis (references?). In this project, we hypothesize that the alteration of skin microbiome as well as changes in metabolite profiles can be associated with the mechanism of the disease. The skin microbiome data generated in this study will be analyzed for microbial profiles using the QIIME2, a next-generation microbiome bioinformatics platform, and a graphic software package, "Statistical Analysis of Taxonomic and Functional Profiles" (STAMP). In parallel, we will apply a high throughput gas chromatography mass-spectrometry-based metabolomics to detect volatile metabolites present in foot odor in association with the observed foot-skin microbiome. This metabolite information will not only provide an additional aspect of pathogenesis of the disease but also might offer a new standard indicator of foot odor that can be further used in clinical practice. Finally, skin microbiome and metabolomic data will be analyzed using various methods of correlation analysis as well as integrative analysis to gain deeper understanding of the disease mechanism at the molecular levels.

The outcomes of this project will provide insights into the pathogenesis of pitted keratolysis. The scientific knowledge gained from the study will be translated into a more effective treatment of the disease. The human microbiome of healthy population and the disease-specific microbiome data will lay the groundwork to develop a human microbiome database for Thai people. Additionally, the success of the project will allow the development of advanced instrumental methodology and an integrative analysis approach to analyze multi -omics data, which will be great assets in advancing multidisciplinary research.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Naval rating cadets at Chumpol Naval Rating School, Thailand who volunteer to participate in this study. Informed consent will be obtained from all participants.
  • Age ≥ 18 years.
  • No underlying disease.
  • Normal BMI (18.5-22.9 kg/m2).
  • No previous history of pitted keratolysis.
  • No previous history of dermatophytosis complex.
  • Refrain from washing their feet for 12 hours prior to sampling.

排除标准

  • Volunteers who have taken medication or topical antibiotics for pitted keratolysis within 2 weeks before the enrollment.
  • Volunteers who have taken oral antibiotics within 2 weeks before enrollment.

研究组 & 干预措施

Foot odor without pitted keratolysis

Experimental
  • Swab their feet to analyze foot microbiome via 16s DNA sequencing
  • Collect their socks to analyze metabolomics via gas chromatography
  • Apply 4% chlorhexidine for 2 weeks
  • Re-evaluate their feet at time of treatment finish and 1 months after treatment finish. The forementioned methods (swab and collect their socks) will be applied on their feet again.
  • The microbiome and metabolomics will be analyzed to evaluate the difference of microbe and substances after treatment.

干预措施: 4%Chlorhexidine (Drug)

Foot odor with pitted keratolysis

Experimental
  • Swab their feet to analyze foot microbiome via 16s DNA sequencing
  • Collect their socks to analyze metabolomics via gas chromatography
  • Apply 4% chlorhexidine for 2 weeks
  • Re-evaluate their feet at time of treatment finish and 1 months after treatment finish. The forementioned methods (swab and collect their socks) will be applied on their feet again.
  • The microbiome and metabolomics will be analyzed to evaluate the difference of microbe and substances after treatment.

干预措施: 4%Chlorhexidine (Drug)

结局指标

主要结局

Composition of microbiota at skin

时间窗: 2 months

Foot-skin microbial profiles of healthy Thai people and patients with pitted keratolysis

Amount of skin microbiome

时间窗: 2 months

Foot-skin microbial profiles of healthy Thai people and patients with pitted keratolysis

次要结局

  • Amount of metabolite in foot odor(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charussri Leeyaphan

Associate Professor

Mahidol University

研究点 (1)

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