Intensive Care UnitNCT06524765
Intestinal Microbiota and Their Antibiotic Resistance Genes of ICU Health Care Workers
An observational study of Intensive Care Unit, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Unit
- What is being tested?
- Living conditions
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2024to 16 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: Comparison of Intestinal Microbes and Their Antibiotic Resistance Genes in ICU Health Care Workers and Non-medical Professionals
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.
- Conditions
- Intensive Care Unit
- Being tested
- Living conditions
- Keywords
- intestinal microbiota, metagenomic sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living conditionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within three days after inclusion.
Secondary outcomes (5)
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.
Measured: Within three days after inclusion.
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.
Measured: Within three days after inclusion.
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.
Measured: Within three days after inclusion.
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.
Measured: Within three days after inclusion.
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.
Measured: Within three days after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start4 Aug 2024
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiancheng Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524765
- Sponsor's protocol ID
- zjc202403
- Status last verified
- Dec 2024
- First submitted
- 11 Jul 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intestinal Microbes and Their Antibiotic Resistance Genes in ICU Health Care Workers and Non-medical Professionals
- ClinicalTrials.gov ID
- NCT06524765
- Acronym / sponsor ID
- zjc202403
- Conditions
- Intensive Care Unit
- Keywords
- intestinal microbiota, metagenomic sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 4 Aug 2024 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU health care workers (exposed group) | – | Other: Living conditionsThe 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. |
| Non-medical professionals (non-exposed group) | – | –This group is a non-exposed group, so the exposed factor is the daily living environment. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Living conditionsThere 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. | Other | ICU health care workers (exposed group) |
Primary outcome
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.
5 secondary outcomes
Patient Health Questionnaire (PHQ-9) score.
Time frame: Within three days after inclusion.
Symptom checklist 90 (SCL-90) score
Time frame: Within three days after inclusion.
Perceived Stress Scale (PSS) score
Time frame: Within three days after inclusion.
International Physical Activity Questionnaire (IPAQ) score
Time frame: Within three days after inclusion.
Pittsburgh sleep quality indexs (PSQI) score
Time frame: Within three days after inclusion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences of antibiotic resistance genes-within the gut microbiota (time frame: Within three days after inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.