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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06524765
Enrollment
78
Registered
2024-07-29
Start date
2024-08-04
Completion date
2024-10-16
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit

Keywords

intestinal microbiota, metagenomic sequencing

Brief 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.

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.

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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
Yes

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Differences of antibiotic resistance genes-within the gut microbiotaWithin 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

MeasureTime frameDescription
Patient Health Questionnaire (PHQ-9) score.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.
Symptom checklist 90 (SCL-90) scoreWithin 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.
Perceived Stress Scale (PSS) scoreWithin 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.
International Physical Activity Questionnaire (IPAQ) scoreWithin 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.
Pittsburgh sleep quality indexs (PSQI) scoreWithin 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026