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

NCT06524765 | Completed

• 1 other identifier: zjc202403
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit

Keywords

intestinal microbiota; metagenomic sequencing

Outcome Measures

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.

  Within three days after inclusion.

Secondary Outcomes (5)

• Patient Health Questionnaire (PHQ-9) 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.

• International Physical Activity Questionnaire (IPAQ) score

  Within three days after inclusion.

• Pittsburgh sleep quality indexs (PSQI) score

  Within three days after inclusion.

Study Arms (2)

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

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.

ICU health care workers (exposed group)

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Interventions

Social Conditions

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Jiancheng Zhang

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 29, 2024
• Study Start: August 4, 2024
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

CN (1)