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Completed

NCT Number: NCT06524765

Intestinal Microbiota and Their Antibiotic Resistance Genes of ICU Health Care Workers

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.

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Key information

Conditions

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Living conditions

Other

There are many patients with multi-resistant bacterial infections in intensive care units (ICU), making it possible for a great deal of these pathogens to exist in the ICU environment. The exposure factors in this study were ICU environment or daily living environment.

Primary outcomes

  1. Differences of antibiotic resistance genes-within the gut microbiota

    Time frame: 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.

Secondary outcomes

  1. Patient Health Questionnaire (PHQ-9) score.

    Time frame: Within three days after inclusion.

    Correlation analysis of the relationship between the antibiotic resistance genes and the PHQ-9 score in ICU health care workers and non-medical professionals.

  2. Symptom checklist 90 (SCL-90) score

    Time frame: Within three days after inclusion.

    Correlation analysis of the relationship between the antibiotic resistance genes and the SCL-90 score in ICU health care workers and non-medical professionals.

  3. Perceived Stress Scale (PSS) score

    Time frame: Within three days after inclusion.

    Correlation analysis of the relationship between the antibiotic resistance genes and the PSS score in ICU health care workers and non-medical professionals.

  4. International Physical Activity Questionnaire (IPAQ) score

    Time frame: Within three days after inclusion.

    Correlation analysis of the relationship between the antibiotic resistance genes and the IPAQ score in ICU health care workers and non-medical professionals.

  5. Pittsburgh sleep quality indexs (PSQI) score

    Time frame: Within three days after inclusion.

    Correlation analysis of the relationship between the antibiotic resistance genes and the PSQI score in ICU health care workers and non-medical professionals.

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 29, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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