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CompletedNCT06524765Updated Dec 10, 2024

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

An observational study in Intensive Care Unit, sponsored by Wuhan Union Hospital, China. Completed at 1 site in China. Open to participants aged 25 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-10.

Sponsored by Wuhan Union Hospital, China · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
78
Ages
25 Years to 40 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Intensive Care Unit

Keywords

  • intestinal microbiota
  • metagenomic sequencing
03

In context

Lead sponsor

Wuhan Union Hospital, China is the lead sponsor of 230 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants were enrolled according to strict inclusion and exclusion criteria and divided into ICU health care workers or non-medical professionals according to exposed factors.

Inclusion criteria

  1. 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.
  2. 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

Exclusion Criteria:

  1. Active gastrointestinal infection or chronic gastrointestinal disease;
  2. Significant dietary changes or significant weight fluctuations (gain or loss > 5 kg) within 3 months;
  3. Antibiotics, proton pump inhibitors or prebiotics, probiotics , including yogurt, have been used in the past 4 weeks;
  4. Drinking within the past week;
  5. 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;
  6. History of major gastrointestinal surgery;
  7. Chronic diseases that may affect the gut microbiota;
  8. Congenital or acquired immunodeficiency disease;
  9. Do not agree to provide information about their diet, exercise and other lifestyle factors that may affect the composition of their microbiome;
  10. Pregnant or lactating women;
  11. Participate in other clinical studies at the time of enrollment or within 3 months before enrollment;
  12. Do not agree to sign a written informed consent.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
78 participants (actual)
Patient registry
No

Groups and cohorts

  • ICU health care workers (exposed group)

    The infection rate of multidrug-resistant bacteria in critically ill patients in intensive care unit (ICU) is high, the mortality rate of infected patients is high, which becomes the 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 full of pathogens and even drug-resistant bacteria, and this high-risk contact and exposure makes many pathogenic microorganisms and their drug-resistant genes become part of the intestinal microbiota of ICU medical staff and are carried. Therefore, the exposure factor of the exposure group in this study was ICU environment.

    Other: Living conditions

  • Non-medical professionals (non-exposed group)

    This group is a non-exposed group, so the exposed factor is the daily living environment.

Interventions

  • OtherLiving conditions

    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.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: Within three days after inclusion.

Secondary outcomes

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

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

    Time frame: Within three days after inclusion.

  2. Symptom checklist 90 (SCL-90) score

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

    Time frame: Within three days after inclusion.

  3. Perceived Stress Scale (PSS) score

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

    Time frame: Within three days after inclusion.

  4. International Physical Activity Questionnaire (IPAQ) score

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

    Time frame: Within three days after inclusion.

  5. Pittsburgh sleep quality indexs (PSQI) score

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

    Time frame: Within three days after inclusion.

07

Study locations

1 site
  • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06524765
Lead sponsor
Wuhan Union Hospital, China
Responsible party
Jiancheng Zhang (Prof. Jiancheng Zhang, Wuhan Union Hospital, China) — Principal investigator
First posted
Jul 29, 2024
Start date
Aug 4, 2024
Primary completion
Oct 16, 2024
Completion
Oct 16, 2024
Last update
Dec 10, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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