Stress Disorders, Post-TraumaticAGMFMSSNCT04443075
Alterations of Gut Microbiome in the Frontline Medical Staff Under the Stress
An observational study of Stress Disorders, Post-Traumatic, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
With the outbreak of 2019 novel coronavirus (2019-nCoV), the frontline medical workers faced enormous stress, including a high risk of infection and inadequate protection from contamination, isolation, patients with negative emotions, a lack of contact with their families, and exhaustion, which may cause mental health… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- faecal sample collector
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2020to 24 Dec 2020
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: They are all medical staff in First Affiliated Hospital of Xi'an Jiaotong University
Who may be able to join
- taking part in the medical team to support Wuhan
- of 18 to 50 years old
- did not take antibiotics within 3 months before sample collection
- 17.5<body mass index (BMI)<30
Who cannot join
- have serious cardiovascular disease, blood disease, and endocrine disease
- have a history of cancer or its complications
- have active gastrointestinal diseases or complications and serious systemic diseases
- have history of brain organic diseases or complications and mental retardation
- have mental disorders such as mood disorder and anxiety disorders
- pregnant or lactating
- drink in the past week (liquor>250ml or beer>1bottle) or the previous day (liquor>50ml or beer>50ml)
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: Alterations of Gut Microbiome in the Frontline Medical Staff Under the Stress of Fighting Against 2019-nCoV
With the outbreak of 2019 novel coronavirus (2019-nCoV), the frontline medical workers faced enormous stress, including a high risk of infection and inadequate protection from contamination, isolation, patients with negative emotions, a lack of contact with their families, and exhaustion, which may cause mental health problems. The investigators plan to collect the faecal samples and clinical assessments from a part of frontline medical workers in three time points to analyse the changing profile of gut microbiome according to outcomes of 16s rRNA sequencing. The samples from the matched health controls will also be sequenced to compare with the exposed group in gut microbiome community.
Read the detailed description
In December, 2019, a novel coronavirus outbreak of pneumonia emerged in Wuhan, Hubei province, China, and has subsequently spread to more than 30 provinces in China and almost 100 countries in the world. In the fight against the 2019 novel coronavirus (2019-nCoV), medical workers in Wuhan have been facing enormous stress, including a high risk of infection and inadequate protection from contamination, isolation, patients with negative emotions, a lack of contact with their families, and exhaustion. The severe situation is causing mental health problems such as stress, anxiety, depressive symptoms, insomnia, denial, anger, and fear. These mental health problems could also cause posttraumatic stress (PTS) symptoms in a lasting time. A research examining the psychological impact of the 2003 outbreak of severe acute respiratory syndrome on hospital empoyees found that about 10% of the respondents had experienced high leves of PTS symptoms since the SARS outbreak.
Microbiome-gut-brain (MGB) axis has been validated in expanding studies, which means there are bidirectional communication between commensal organisms within the gut and the brain. Gut microbiota may influence brain function through neural, endocrine, and immune pathways. For example, substances produced by the gut microbiota may be absorbed reaching the brain by the blood stream. The brain, in turn, may influence the gut microbiota trough neuronal and endocrine pathways. In recent years, many reseaches support the relevance of microbiota and mental health status. Bercik et al. transplanted microbiota from adult germ-free (GF) BALB/c mice (a high-anxiety mouse strain) into adult GF NIH Swiss mice (a low-anxiety mouse strain), then found the behavioral profile of the donor was evident in the recipient animal, showing that the microbiota can directly affect behavior. Moreover, preclinical studies have shown that stress and emotions, including maternal separation and restraint, heat, and acoustic stress, alters the composition of the gut microbiota, maybe through the release of stress hormones or sympathetic neurotransmitters that influence gut physiology and alter the habitat of the microbiota. In addition, researchers found that stress has the ability to increase intestinal permeability, probably through the involvement of corticotrophin releasing factor and its receptors (CRFR1 and CRFR2), which play a key role in stress-induced gut permeability dysfunction. Increased intestinal permeability provides bacteria an opportunity to translocate across the intestinal mucosa and directly access both the immune and neuronal cells of the enteric nervous system (ENS). Stress also activates the autonomic nervous system, which affects gastric acid, bile, and mucus secretion, as well as gut motility. Gut motility is of particular importance since it is strongly associated with gut microbiota composition and richness. Based on these researches, the gut microbiome increasingly deserve attention to understand psychiatric disorders.
Therefore, the present study aim to collect the faecal samples and clinical assessments from a part of frontline medical workers in three time points to analyse the changing profile of gut microbiome according to outcomes of 16s rRNA sequencing. The samples from the matched health controls will also be sequenced to compare with the exposed group in gut microbiome community.
Methods Study design and sample collection The frontline workers in First Affiliated Hospital of Xi'an Jiaotong University will be included if they conformed with (1) taking part in the medical team to support Wuhan, (2) of 18 to 50 years old, (3) did not take antibiotics within 3 months before sample collection, (4) 17.5<body mass index (BMI)<30. The healthy controls will be selected from the staffs in First Affiliated Hospital who didn't join in the medical team but fulfill the last three conditions above to match with the frontline staffs for age, gender, BMI, and diet. Any participant will be excluded if he/she fulfill the following criteria: (1) have serious cardiovascular disease, blood disease, and endocrine disease, (2) have a history of cancer or its complications, (3) have active gastrointestinal diseases or complications and serious systemic diseases, (4) have history of brain organic diseases or complications and mental retardation, (5) have mental disorders such as mood disorder and anxiety disorders, (6) pregnant or lactating, (7) drink in the past week (liquor>250ml or beer>1bottle) or the previous day (liquor>50ml or beer>50ml). All included persons should provide signed informed consent before sample collection, and the protocol was approved by the Ethics Committee of First Affiliated Hospital of Xi'an Jiaotong University (KYLLSL-2020-043). Faecal samples from each staff should be freshly collected at the hospital and frozen at -80℃ using specified faecal collector.
Clinical assessmant PHQ-15, PHQ-9, GAD-7, PSQI, SCL-90, and IES-R will be used for the assessment of clinical symptoms related to psychiatric disorder for exposed group in three time point and non-exposed group.
DNA extraction and 16S rRNA sequencing The investigators will perform 16S rRNA sequencing for all the collected faecal samples. Briefly, bacterial genomic DNA will be extracted, and the 16S rRNA whole region will be amplified by PCR, and then sequenced.
Statistical analysis The 16S rRNA sequencing data will be analysed using Quantitative Insights Into Microbial Ecology (QIIME). The investigators then use usearch to cluster sequences into taxonomic units (OTUs) at 97% identity and construct the OTU table. Microbial community structure, alpha diversity, and beta diversity will be analysed. LEfSe analysis, and random forest analysis will be used to find the biomarker between different group. Spearman's rank correlation will be used to identify the corrolation between clinical assessments and stress-associated microbiome.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- faecal sample collector
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
faecal sample collectorDevice
The frontline medical workers mainly exposed under the stress of fighting against 2019-nCoV
| Study group | Role | What they receive |
|---|---|---|
| exposed group | The exposed group consists of the frontline medical workers who take part in the medical team to support Wuhan. Receives: Device: faecal sample collector | |
| non-exposed group | This group includs medical workers who didn't join in the medical team to support Wuhan. Receives: Device: faecal sample collector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome composition of exposed group
Gut microbiome composition will be anaylysed using 16S rRNA sequencing.
Measured: immediately after the frontline workers come back to Xi'an
Gut microbiome composition of exposed group
Gut microbiome composition will be anaylysed using 16S rRNA sequencing.
Measured: immediately after the frontline workers isolated for two weeks
Gut microbiome composition of exposed group
Gut microbiome composition will be anaylysed using 16S rRNA sequencing.
Measured: immediately after the frontline workers going back to normal work for one month
Gut microbiome composition of non-exposed group
Gut microbiome composition will be anaylysed using 16S rRNA sequencing.
Measured: During the procedure of collecting faecal samples from exposed group
The Impact of Event Scale-Revised (IES-R) of exposed group
It's a self-report measure assessing subjective distress resulting from a traumatic life event, with a total score of 0-88. Higher score means a worse outcome
Measured: immediately after the frontline workers come back to Xi'an
The Impact of Event Scale-Revised (IES-R) of exposed group
It's a self-report measure assessing subjective distress resulting from a traumatic life event, with a total score of 0-88. Higher score means a worse outcome
Measured: immediately after the frontline workers isolated for two weeks
The Impact of Event Scale-Revised (IES-R) of exposed group
It's a self-report measure assessing subjective distress resulting from a traumatic life event, with a total score of 0-88. Higher score means a worse outcome
Measured: immediately after the frontline workers going back to normal work for one month
The Impact of Event Scale-Revised (IES-R) of non-exposed group
It's a self-report measure assessing subjective distress resulting from a traumatic life event, with a total score of 0-88. Higher score means a worse outcome
Measured: During the procedure of collecting faecal samples from non-exposed group
Secondary outcomes (20)
The 15-item Patient Health Questionnaire (PHQ-15) of exposed group
It's a self-administered measure assessing subjective common mental health with a total score of 0-30. Higher score means a worse outcome.
Measured: immediately after the frontline workers come back to Xi'an
The 15-item Patient Health Questionnaire (PHQ-15) of exposed group
It's a self-administered measure assessing subjective common mental health with a total score of 0-30. Higher score means a worse outcome.
Measured: immediately after the frontline workers isolated for two weeks
The 15-item Patient Health Questionnaire (PHQ-15) of exposed group
It's a self-administered measure assessing subjective common mental health with a total score of 0-30. Higher score means a worse outcome.
Measured: immediately after the frontline workers going back to normal work for one month
The 15-item Patient Health Questionnaire-15 (PHQ-15) of non-exposed group
It's a self-administered measure assessing subjective common mental health with a total score of 0-30. Higher score means a worse outcome.
Measured: During the procedure of collecting faecal samples from non-exposed group
The 9-item Patient Health Questionnaire (PHQ-9) of exposed group
It's a self-report measure widely used for major depression screening with a total score of 0-27. Higher score means a worse outcome.
Measured: immediately after the frontline workers come back to Xi'an
The 9-item Patient Health Questionnaire (PHQ-9) of exposed group
It's a self-report measure widely used for major depression screening with a total score of 0-27. Higher score means a worse outcome.
Measured: immediately after the frontline workers isolated for two weeks
The 9-item Patient Health Questionnaire (PHQ-9) of exposed group
It's a self-report measure widely used for major depression screening with a total score of 0-27. Higher score means a worse outcome.
Measured: immediately after the frontline workers going back to normal work for one month
The 9-item Patient Health Questionnaire (PHQ-9) of non-exposed group
It's a self-report measure widely used for major depression screening with a total score of 0-27. Higher score means a worse outcome.
Measured: During the procedure of collecting faecal samples from non-exposed group
The 7-item Generalized Anxiety Disorder Scale (GAD-7) of exposed group
It is a practical self-report anxiety questionnaire with a total score of 0-21. Higher score means a worse outcome.
Measured: immediately after the frontline workers come back to Xi'an
The 7-item Generalized Anxiety Disorder Scale (GAD-7) of exposed group
It is a practical self-report anxiety questionnaire with a total score of 0-21. Higher score means a worse outcome.
Measured: immediately after the frontline workers isolated for two weeks
The 7-item Generalized Anxiety Disorder Scale (GAD-7) of exposed group
It is a practical self-report anxiety questionnaire with a total score of 0-21. Higher score means a worse outcome.
Measured: immediately after the frontline workers going back to normal work for one month
The 7-item Generalized Anxiety Disorder Scale (GAD-7) of non-exposed group
It is a practical self-report anxiety questionnaire with a total score of 0-21. Higher score means a worse outcome.
Measured: During the procedure of collecting faecal samples from non-exposed group
The Pittsburgh Sleep Quality Index (PSQI) of exposed group
It is a self-report questionnaire that is widely used to assess several dimensions of sleep with a total score of 0-21. Higher score means a worse outcome
Measured: immediately after the frontline workers come back to Xi'an
The Pittsburgh Sleep Quality Index (PSQI) of exposed group
It is a self-report questionnaire that is widely used to assess several dimensions of sleep with a total score of 0-21. Higher score means a worse outcome
Measured: immediately after the frontline workers isolated for two weeks
The Pittsburgh Sleep Quality Index (PSQI) of exposed group
It is a self-report questionnaire that is widely used to assess several dimensions of sleep with a total score of 0-21. Higher score means a worse outcome
Measured: immediately after the frontline workers going back to normal work for one month
The Pittsburgh Sleep Quality Index (PSQI) of non-exposed group
It is a self-report questionnaire that is widely used to assess several dimensions of sleep with a total score of 0-21. Higher score means a worse outcome
Measured: During the procedure of collecting faecal samples from non-exposed group
The Symptom Check List 90 (SCL-90) of exposed group
It is a self-report instrument widely used to measure clinical psychiatric symptoms and mental health status, with a total score of 0-360. Higher means a worse outcome.
Measured: immediately after the frontline workers come back to Xi'an
The Symptom Check List 90 (SCL-90) of exposed group
It is a self-report instrument widely used to measure clinical psychiatric symptoms and mental health status, with a total score of 0-360. Higher means a worse outcome.
Measured: immediately after the frontline workers isolated for two weeks
The Symptom Check List 90 (SCL-90) of exposed group
It is a self-report instrument widely used to measure clinical psychiatric symptoms and mental health status, with a total score of 0-360. Higher means a worse outcome.
Measured: immediately after the frontline workers going back to normal work for one month
The Symptom Check List 90 (SCL-90) of non-exposed group
It is a self-report instrument widely used to measure clinical psychiatric symptoms and mental health status, with a total score of 0-360. Higher means a worse outcome.
Measured: During the procedure of collecting faecal samples from non-exposed group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start24 Jun 2020
- Primary completion4 Dec 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiancang Ma, M.D., Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443075
- Sponsor's protocol ID
- XJTU1AF2020LSK-022
- Acronym
- AGMFMSS
- Status last verified
- Mar 2021
- First submitted
- 3 Jun 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. No abstract available.
PubMed 31986257Kang L, Li Y, Hu S, Chen M, Yang C, Yang BX, Wang Y, Hu J, Lai J, Ma X, Chen J, Guan L, Wang G, Ma H, Liu Z. The mental health of medical workers in Wuhan, China dealing with the 2019 novel coronavirus. Lancet Psychiatry. 2020 Mar;7(3):e14. doi: 10.1016/S2215-0366(20)30047-X. Epub 2020 Feb 5. No abstract available.
PubMed 32035030Malan-Muller S, Valles-Colomer M, Raes J, Lowry CA, Seedat S, Hemmings SMJ. The Gut Microbiome and Mental Health: Implications for Anxiety- and Trauma-Related Disorders. OMICS. 2018 Feb;22(2):90-107. doi: 10.1089/omi.2017.0077. Epub 2017 Aug 2.
PubMed 28767318Foster JA, McVey Neufeld KA. Gut-brain axis: how the microbiome influences anxiety and depression. Trends Neurosci. 2013 May;36(5):305-12. doi: 10.1016/j.tins.2013.01.005. Epub 2013 Feb 4.
PubMed 23384445Wu P, Fang Y, Guan Z, Fan B, Kong J, Yao Z, Liu X, Fuller CJ, Susser E, Lu J, Hoven CW. The psychological impact of the SARS epidemic on hospital employees in China: exposure, risk perception, and altruistic acceptance of risk. Can J Psychiatry. 2009 May;54(5):302-11. doi: 10.1177/070674370905400504.
PubMed 19497162Rieder R, Wisniewski PJ, Alderman BL, Campbell SC. Microbes and mental health: A review. Brain Behav Immun. 2017 Nov;66:9-17. doi: 10.1016/j.bbi.2017.01.016. Epub 2017 Jan 25.
PubMed 28131791
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations of Gut Microbiome in the Frontline Medical Staff Under the Stress of Fighting Against 2019-nCoV
- ClinicalTrials.gov ID
- NCT04443075
- Acronym / sponsor ID
- AGMFMSS / XJTU1AF2020LSK-022
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 23 Jun 2020 (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.
With the outbreak of 2019 novel coronavirus (2019-nCoV), the frontline medical workers faced enormous stress, including a high risk of infection and inadequate protection from contamination, isolation, patients with negative emotions, a lack of contact with their families, and exhaustion, which may cause mental health problems. The investigators plan to collect the faecal samples and clinical assessments from a part of frontline medical workers in three time points to analyse the changing profile of gut microbiome according to outcomes of 16s rRNA sequencing. The samples from the matched health controls will also be sequenced to compare with the exposed group in gut microbiome community.
Detailed description
In December, 2019, a novel coronavirus outbreak of pneumonia emerged in Wuhan, Hubei province, China, and has subsequently spread to more than 30 provinces in China and almost 100 countries in the world. In the fight against the 2019 novel coronavirus (2019-nCoV), medical workers in Wuhan have been facing enormous stress, including a high risk of infection and inadequate protection from contamination, isolation, patients with negative emotions, a lack of contact with their families, and exhaustion. The severe situation is causing mental health problems such as stress, anxiety, depressive symptoms, insomnia, denial, anger, and fear. These mental health problems could also cause posttraumatic stress (PTS) symptoms in a lasting time. A research examining the psychological impact of the 2003 outbreak of severe acute respiratory syndrome on hospital empoyees found that about 10% of the respondents had experienced high leves of PTS symptoms since the SARS outbreak.
Microbiome-gut-brain (MGB) axis has been validated in expanding studies, which means there are bidirectional communication between commensal organisms within the gut and the brain. Gut microbiota may influence brain function through neural, endocrine, and immune pathways. For example, substances produced by the gut microbiota may be absorbed reaching the brain by the blood stream. The brain, in turn, may influence the gut microbiota trough neuronal and endocrine pathways. In recent years, many reseaches support the relevance of microbiota and mental health status. Bercik et al. transplanted microbiota from adult germ-free (GF) BALB/c mice (a high-anxiety mouse strain) into adult GF NIH Swiss mice (a low-anxiety mouse strain), then found the behavioral profile of the donor was evident in the recipient animal, showing that the microbiota can directly affect behavior. Moreover, preclinical studies have shown that stress and emotions, including maternal separation and restraint, heat, and acoustic stress, alters the composition of the gut microbiota, maybe through the release of stress hormones or sympathetic neurotransmitters that influence gut physiology and alter the habitat of the microbiota. In addition, researchers found that stress has the ability to increase intestinal permeability, probably through the involvement of corticotrophin releasing factor and its receptors (CRFR1 and CRFR2), which play a key role in stress-induced gut permeability dysfunction. Increased intestinal permeability provides bacteria an opportunity to translocate across the intestinal mucosa and directly access both the immune and neuronal cells of the enteric nervous system (ENS). Stress also activates the autonomic nervous system, which affects gastric acid, bile, and mucus secretion, as well as gut motility. Gut motility is of particular importance since it is strongly associated with gut microbiota composition and richness. Based on these researches, the gut microbiome increasingly deserve attention to understand psychiatric disorders.
Therefore, the present study aim to collect the faecal samples and clinical assessments from a part of frontline medical workers in three time points to analyse the changing profile of gut microbiome according to outcomes of 16s rRNA sequencing. The samples from the matched health controls will also be sequenced to compare with the exposed group in gut microbiome community.
Methods Study design and sample collection The frontline workers in First Affiliated Hospital of Xi'an Jiaotong University will be included if they conformed with (1) taking part in the medical team to support Wuhan, (2) of 18 to 50 years old, (3) did not take antibiotics within 3 months before sample collection, (4) 17.5<body mass index (BMI)<30. The healthy controls will be selected from the staffs in First Affiliated Hospital who didn't join in the medical team but fulfill the last three conditions above to match with the frontline staffs for age, gender, BMI, and diet. Any participant will be excluded if he/she fulfill the following criteria: (1) have serious cardiovascular disease, blood disease, and endocrine disease, (2) have a history of cancer or its complications, (3) have active gastrointestinal diseases or complications and serious systemic diseases, (4) have history of brain organic diseases or complications and mental retardation, (5) have mental disorders such as mood disorder and anxiety disorders, (6) pregnant or lactating, (7) drink in the past week (liquor>250ml or beer>1bottle) or the previous day (liquor>50ml or beer>50ml). All included persons should provide signed informed consent before sample collection, and the protocol was approved by the Ethics Committee of First Affiliated Hospital of Xi'an Jiaotong University (KYLLSL-2020-043). Faecal samples from each staff should be freshly collected at the hospital and frozen at -80℃ using specified faecal collector.
Clinical assessmant PHQ-15, PHQ-9, GAD-7, PSQI, SCL-90, and IES-R will be used for the assessment of clinical symptoms related to psychiatric disorder for exposed group in three time point and non-exposed group.
DNA extraction and 16S rRNA sequencing The investigators will perform 16S rRNA sequencing for all the collected faecal samples. Briefly, bacterial genomic DNA will be extracted, and the 16S rRNA whole region will be amplified by PCR, and then sequenced.
Statistical analysis The 16S rRNA sequencing data will be analysed using Quantitative Insights Into Microbial Ecology (QIIME). The investigators then use usearch to cluster sequences into taxonomic units (OTUs) at 97% identity and construct the OTU table. Microbial community structure, alpha diversity, and beta diversity will be analysed. LEfSe analysis, and random forest analysis will be used to find the biomarker between different group. Spearman's rank correlation will be used to identify the corrolation between clinical assessments and stress-associated microbiome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposed group | – | Device: faecal sample collectorThe exposed group consists of the frontline medical workers who take part in the medical team to support Wuhan. |
| non-exposed group | – | Device: faecal sample collectorThis group includs medical workers who didn't join in the medical team to support Wuhan. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- They are all medical staff in First Affiliated Hospital of Xi'an Jiaotong University
Key inclusion criteria (4 listed)
- taking part in the medical team to support Wuhan
- of 18 to 50 years old
- did not take antibiotics within 3 months before sample collection
- 17.5<body mass index (BMI)<30
Key exclusion criteria (7 listed)
- have serious cardiovascular disease, blood disease, and endocrine disease
- have a history of cancer or its complications
- have active gastrointestinal diseases or complications and serious systemic diseases
- have history of brain organic diseases or complications and mental retardation
- have mental disorders such as mood disorder and anxiety disorders
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 |
|---|---|---|
| faecal sample collectorThe frontline medical workers mainly exposed under the stress of fighting against 2019-nCoV | Device | exposed group, non-exposed group |
Primary outcome
Gut microbiome composition of exposed group
Time frame: immediately after the frontline workers come back to Xi'an
Gut microbiome composition will be anaylysed using 16S rRNA sequencing.
Gut microbiome composition of exposed group
Time frame: immediately after the frontline workers isolated for two weeks
Gut microbiome composition will be anaylysed using 16S rRNA sequencing.
Gut microbiome composition of exposed group
Time frame: immediately after the frontline workers going back to normal work for one month
Gut microbiome composition will be anaylysed using 16S rRNA sequencing.
Gut microbiome composition of non-exposed group
Time frame: During the procedure of collecting faecal samples from exposed group
Gut microbiome composition will be anaylysed using 16S rRNA sequencing.
The Impact of Event Scale-Revised (IES-R) of exposed group
Time frame: immediately after the frontline workers come back to Xi'an
It's a self-report measure assessing subjective distress resulting from a traumatic life event, with a total score of 0-88. Higher score means a worse outcome
The Impact of Event Scale-Revised (IES-R) of exposed group
Time frame: immediately after the frontline workers isolated for two weeks
It's a self-report measure assessing subjective distress resulting from a traumatic life event, with a total score of 0-88. Higher score means a worse outcome
The Impact of Event Scale-Revised (IES-R) of exposed group
Time frame: immediately after the frontline workers going back to normal work for one month
It's a self-report measure assessing subjective distress resulting from a traumatic life event, with a total score of 0-88. Higher score means a worse outcome
The Impact of Event Scale-Revised (IES-R) of non-exposed group
Time frame: During the procedure of collecting faecal samples from non-exposed group
It's a self-report measure assessing subjective distress resulting from a traumatic life event, with a total score of 0-88. Higher score means a worse outcome
20 secondary outcomes
The 15-item Patient Health Questionnaire (PHQ-15) of exposed group
Time frame: immediately after the frontline workers come back to Xi'an
The 15-item Patient Health Questionnaire (PHQ-15) of exposed group
Time frame: immediately after the frontline workers isolated for two weeks
The 15-item Patient Health Questionnaire (PHQ-15) of exposed group
Time frame: immediately after the frontline workers going back to normal work for one month
The 15-item Patient Health Questionnaire-15 (PHQ-15) of non-exposed group
Time frame: During the procedure of collecting faecal samples from non-exposed group
The 9-item Patient Health Questionnaire (PHQ-9) of exposed group
Time frame: immediately after the frontline workers come back to Xi'an
The 9-item Patient Health Questionnaire (PHQ-9) of exposed group
Time frame: immediately after the frontline workers isolated for two weeks
The 9-item Patient Health Questionnaire (PHQ-9) of exposed group
Time frame: immediately after the frontline workers going back to normal work for one month
The 9-item Patient Health Questionnaire (PHQ-9) of non-exposed group
Time frame: During the procedure of collecting faecal samples from non-exposed group
The 7-item Generalized Anxiety Disorder Scale (GAD-7) of exposed group
Time frame: immediately after the frontline workers come back to Xi'an
The 7-item Generalized Anxiety Disorder Scale (GAD-7) of exposed group
Time frame: immediately after the frontline workers isolated for two weeks
The 7-item Generalized Anxiety Disorder Scale (GAD-7) of exposed group
Time frame: immediately after the frontline workers going back to normal work for one month
The 7-item Generalized Anxiety Disorder Scale (GAD-7) of non-exposed group
Time frame: During the procedure of collecting faecal samples from non-exposed group
The Pittsburgh Sleep Quality Index (PSQI) of exposed group
Time frame: immediately after the frontline workers come back to Xi'an
The Pittsburgh Sleep Quality Index (PSQI) of exposed group
Time frame: immediately after the frontline workers isolated for two weeks
The Pittsburgh Sleep Quality Index (PSQI) of exposed group
Time frame: immediately after the frontline workers going back to normal work for one month
The Pittsburgh Sleep Quality Index (PSQI) of non-exposed group
Time frame: During the procedure of collecting faecal samples from non-exposed group
The Symptom Check List 90 (SCL-90) of exposed group
Time frame: immediately after the frontline workers come back to Xi'an
The Symptom Check List 90 (SCL-90) of exposed group
Time frame: immediately after the frontline workers isolated for two weeks
The Symptom Check List 90 (SCL-90) of exposed group
Time frame: immediately after the frontline workers going back to normal work for one month
The Symptom Check List 90 (SCL-90) of non-exposed group
Time frame: During the procedure of collecting faecal samples from non-exposed group
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 3 Mar 2021.
- Background: PubMed 31986257Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. No abstract available.
- Background: PubMed 32035030Kang L, Li Y, Hu S, Chen M, Yang C, Yang BX, Wang Y, Hu J, Lai J, Ma X, Chen J, Guan L, Wang G, Ma H, Liu Z. The mental health of medical workers in Wuhan, China dealing with the 2019 novel coronavirus. Lancet Psychiatry. 2020 Mar;7(3):e14. doi: 10.1016/S2215-0366(20)30047-X. Epub 2020 Feb 5. No abstract available.
- Background: PubMed 28767318Malan-Muller S, Valles-Colomer M, Raes J, Lowry CA, Seedat S, Hemmings SMJ. The Gut Microbiome and Mental Health: Implications for Anxiety- and Trauma-Related Disorders. OMICS. 2018 Feb;22(2):90-107. doi: 10.1089/omi.2017.0077. Epub 2017 Aug 2.
- Background: PubMed 23384445Foster JA, McVey Neufeld KA. Gut-brain axis: how the microbiome influences anxiety and depression. Trends Neurosci. 2013 May;36(5):305-12. doi: 10.1016/j.tins.2013.01.005. Epub 2013 Feb 4.
- Background: PubMed 19497162Wu P, Fang Y, Guan Z, Fan B, Kong J, Yao Z, Liu X, Fuller CJ, Susser E, Lu J, Hoven CW. The psychological impact of the SARS epidemic on hospital employees in China: exposure, risk perception, and altruistic acceptance of risk. Can J Psychiatry. 2009 May;54(5):302-11. doi: 10.1177/070674370905400504.
- Background: PubMed 28131791Rieder R, Wisniewski PJ, Alderman BL, Campbell SC. Microbes and mental health: A review. Brain Behav Immun. 2017 Nov;66:9-17. doi: 10.1016/j.bbi.2017.01.016. Epub 2017 Jan 25.
- Individual participant dataSharing planned: Undecided
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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.
Xiancang Ma, M.D. principal investigator
First Affiliated Hospital Xi'an Jiaotong University
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 Stress Disorders, Post-Traumatic, run by First Affiliated Hospital Xi'an Jiaotong University 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 4 inclusion and 7 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 3 Mar 2021. 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?
Gut microbiome composition of exposed group (time frame: immediately after the frontline workers come back to Xi'an). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04443075, which also lists 6 linked publications.
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 3 Mar 2021.