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临床试验/NCT06228248
NCT06228248已完成不适用

Characterizing the Differences in Gut Microbiome Antibiotics Resistance Gene Between Healthcare Workers and the Healthy Population

First Affiliated Hospital of Zhejiang University8 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
250
试验地点
8
主要终点
Differences in GUT ARG abundance between two groups

研究概览

简要总结

Multidrug resistant bacteria (MDR) pose a threat to the safety of patients worldwide. Drug resistant bacteria are commonly present in hospital environments and can cause infections, often leading to outbreaks within hospitals. Cross transmission through medical staff has been proven to be a significant cause of MDR bacterial transmission in hospitals. Although some studies have shown that the detection of gut drug-resistant bacteria in healthcare workers is similar to that in healthy individuals, these studies are limited to small sample sizes and detection methods. Here, the investigator characterize the differences between ARG colonization among healthcare workers and healthy populations through deep metagenomics.

详细描述

Understanding the antibiotic resistant genes in the intestinal microbiome of medical workers can reveal their exposure history to antibiotics and the status of antibiotic resistance. The gut microbiome of medical staff may be one of the important sources of MDR transmission. The contact between medical staff and patients is one of the main ways of MDR transmission in hospitals. Understanding the types and distribution of antibiotic resistant genes of gut microbiome of medical workers can assess the risk of MDR transmission in the hospital, help to assess them as the potential source of MDR transmission, and then take targeted prevention and control measures.

In order to better understand the role of medical staff in the transmission of MDR, it is necessary to conduct research on larger sample size and more sensitive detection methods. Metagenomics studies the genomes of all microorganisms in the microbial ecological community. It constructs a metagenomic library by directly extracting the DNA or RNA of all microorganisms from environmental samples, studies the species composition and functional composition of the community, the interaction of different microorganisms in the same population, and the interaction between microbial communities and hosts, and makes a comparative analysis of samples with different phenotypes. With the characteristics of high data flux, low cost and fast speed, it has become a powerful tool for the study of gut microbe.

To sum up, MDR poses a serious threat to global security. In order to deal with this problem, more in-depth and comprehensive research is needed to understand the transmission route of MDR in the hospital. The investigator evaluated the difference between the gut microbe antibiotic resistant genes abundance of medical workers, especially medical workers in the ICU, and healthy people through in-depth sequencing, which helps to provide information on the potential role of medical staff in the transmission of MDR, and is essential for formulating effective prevention and control strategies.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than 18 years old
  • The subjects fully understand and sign the informed consent form

排除标准

  • Existence of gastrointestinal diseases, malignant tumors, and psychiatric disorders
  • Have taken broad-spectrum antibiotics within 6 months
  • Pregnant women
  • For healthy control:
  • Inclusion Criteria:
  • Age greater than 18 years old
  • The subjects fully understand and sign the informed consent form
  • Exclusion Criteria:
  • Previously or currently engaged in medical related work
  • Existence of gastrointestinal diseases, malignant tumors, and psychiatric disorders
  • Have taken broad-spectrum antibiotics within 6 months
  • Pregnant women

结局指标

主要结局

Differences in GUT ARG abundance between two groups

时间窗: 1 year

After conducting metagenomic testing, the investigator will analyze the raw data according to the preset protocol process and report the gut ARG abundance of different individuals. Subsequently, the difference in ARG abundance between the two groups of patients will be compared.

次要结局

  • The association of occupational exposure time in the ICU environment and ARG(1 year)

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lingtong Huang, MD

Principal investigator

First Affiliated Hospital of Zhejiang University

研究点 (8)

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