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临床试验/NCT06524765
NCT06524765已完成不适用

Comparison of Intestinal Microbes and Their Antibiotic Resistance Genes in ICU Health Care Workers and Non-medical Professionals

Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年8月4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
78
试验地点
1
主要终点
Differences of antibiotic resistance genes-within the gut microbiota

研究概览

简要总结

In this study, metagenomic sequencing (10G) results of stool samples from health care workers in ICU and non-medical professionals were compared to observe whether there are significant differences in community diversity, structure and function of intestinal microbiota and whether there are drug resistance genes carried by intestinal microbes, so as to determine whether long-term exposure to multi-pathogen environment in ICU has an impact on intestinal microbiota.

详细描述

The infection rate of multidrug-resistant bacteria in critically ill patients in intensive care unit (ICU) is high, resulting in high mortality, prolonged hospitalization, and becoming a source of pathogen transmission. The front-line medical staff engaged in ICU are constantly in contact with patients and exposed to the intensive care unit (ICU) environment, and this high-risk contact and exposure makes many pathogenic microorganisms and their drug-resistance genes become part of the intestinal microbiota of ICU medical staff and are carried. So far, there have been no previous reports on the characteristics of intestinal microbiome and the drug resistance genes carried by ICU staff. Therefore, in this study, metagenomic sequencing (10G) results of stool samples from medical staff and non-medical professionals in ICU were compared to observe whether there are significant differences in community diversity, structure and function of intestinal microbiota and whether there are drug resistance genes carried by intestinal microbes, so as to determine whether long-term exposure to multi-pathogen environment in ICU has an impact on intestinal microbiota.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
25 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Inclusion criteria for ICU health care workers: 25≤ age ≤40 years old, regardless of ethnicity or gender; Doctors and nurses who provide direct treatment and care for ICU patients, who have been working in ICU for ≥5 years, and who have been absent from frontline work continuously for < 1 month; Agree to sign informed consent.
  • •Inclusion criteria for non-medical professionals: 25≤ age ≤40 years old, regardless of ethnicity or gender; Age, sex, and body mass index matched with ICU medical staff; No hospitalization within the last year; Not an ICU health care worker or does not live with an ICU health care worker; Agree to sign informed consent.

排除标准

  • •Active gastrointestinal infection or chronic gastrointestinal disease;
  • •Significant dietary changes or significant weight fluctuations (gain or loss > 5 kg) within 3 months;
  • •Antibiotics, proton pump inhibitors or prebiotics, probiotics , including yogurt, have been used in the past 4 weeks;
  • •Drinking within the past week;
  • •Those who have recently been treated with high-risk immunosuppressive or cytotoxic drugs, such as medium-high dose steroid hormones (20 mg/day or higher) for more than 4 weeks;
  • •History of major gastrointestinal surgery;
  • •Chronic diseases that may affect the gut microbiota;
  • •Congenital or acquired immunodeficiency disease;
  • •Do not agree to provide information about their diet, exercise and other lifestyle factors that may affect the composition of their microbiome;
  • •Pregnant or lactating women;
  • •Participate in other clinical studies at the time of enrollment or within 3 months before enrollment;
  • •Do not agree to sign a written informed consent.

结局指标

主要结局

Differences of antibiotic resistance genes-within the gut microbiota

时间窗: Within three days after inclusion.

Metagenomic sequencing (10G) will be performed on three days after inclusion, to compare the differences of antibiotic resistance genes-within the gut microbiota between ICU health care workers and non-medical professionals.

次要结局

  • International Physical Activity Questionnaire (IPAQ) score(Within three days after inclusion.)
  • Pittsburgh sleep quality indexs (PSQI) score(Within three days after inclusion.)
  • Symptom checklist 90 (SCL-90) score(Within three days after inclusion.)
  • Perceived Stress Scale (PSS) score(Within three days after inclusion.)
  • Patient Health Questionnaire (PHQ-9) score.(Within three days after inclusion.)

研究者

发起方
Wuhan Union Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiancheng Zhang

Prof. Jiancheng Zhang

Wuhan Union Hospital, China

研究点 (1)

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