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Alterations of Gut Microbiome in the Frontline Medical Staff Under the Stress (AGMFMSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04443075
Recruitment Status : Completed
First Posted : June 23, 2020
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Brief 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 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.

Condition or disease Intervention/treatment
Stress Disorders, Post-Traumatic Device: faecal sample collector

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Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alterations of Gut Microbiome in the Frontline Medical Staff Under the Stress of Fighting Against 2019-nCoV
Actual Study Start Date : June 24, 2020
Actual Primary Completion Date : December 4, 2020
Actual Study Completion Date : December 24, 2020

Group/Cohort Intervention/treatment
exposed group
The exposed group consists of the frontline medical workers who take part in the medical team to support Wuhan.
Device: faecal sample collector
The frontline medical workers mainly exposed under the stress of fighting against 2019-nCoV

non-exposed group
This group includs medical workers who didn't join in the medical team to support Wuhan.
Device: faecal sample collector
The frontline medical workers mainly exposed under the stress of fighting against 2019-nCoV




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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


Secondary Outcome Measures :
  1. The 15-item Patient Health Questionnaire (PHQ-15) of exposed group [ Time Frame: immediately after the frontline workers come back to Xi'an ]
    It's a self-administered measure assessing subjective common mental health with a total score of 0-30. Higher score means a worse outcome.

  2. The 15-item Patient Health Questionnaire (PHQ-15) of exposed group [ Time Frame: immediately after the frontline workers isolated for two weeks ]
    It's a self-administered measure assessing subjective common mental health with a total score of 0-30. Higher score means a worse outcome.

  3. 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 ]
    It's a self-administered measure assessing subjective common mental health with a total score of 0-30. Higher score means a worse outcome.

  4. 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 ]
    It's a self-administered measure assessing subjective common mental health with a total score of 0-30. Higher score means a worse outcome.

  5. The 9-item Patient Health Questionnaire (PHQ-9) of exposed group [ Time Frame: immediately after the frontline workers come back to Xi'an ]
    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.

  6. The 9-item Patient Health Questionnaire (PHQ-9) of exposed group [ Time Frame: immediately after the frontline workers isolated for two weeks ]
    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.

  7. 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 ]
    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.

  8. 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 ]
    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.

  9. The 7-item Generalized Anxiety Disorder Scale (GAD-7) of exposed group [ Time Frame: immediately after the frontline workers come back to Xi'an ]
    It is a practical self-report anxiety questionnaire with a total score of 0-21. Higher score means a worse outcome.

  10. The 7-item Generalized Anxiety Disorder Scale (GAD-7) of exposed group [ Time Frame: immediately after the frontline workers isolated for two weeks ]
    It is a practical self-report anxiety questionnaire with a total score of 0-21. Higher score means a worse outcome.

  11. 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 ]
    It is a practical self-report anxiety questionnaire with a total score of 0-21. Higher score means a worse outcome.

  12. 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 ]
    It is a practical self-report anxiety questionnaire with a total score of 0-21. Higher score means a worse outcome.

  13. The Pittsburgh Sleep Quality Index (PSQI) of exposed group [ Time Frame: immediately after the frontline workers come back to Xi'an ]
    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

  14. The Pittsburgh Sleep Quality Index (PSQI) of exposed group [ Time Frame: immediately after the frontline workers isolated for two weeks ]
    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

  15. The Pittsburgh Sleep Quality Index (PSQI) of exposed group [ Time Frame: immediately after the frontline workers going back to normal work for one month ]
    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

  16. The Pittsburgh Sleep Quality Index (PSQI) of non-exposed group [ Time Frame: During the procedure of collecting faecal samples from 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

  17. The Symptom Check List 90 (SCL-90) of exposed group [ Time Frame: immediately after the frontline workers come back to Xi'an ]
    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.

  18. The Symptom Check List 90 (SCL-90) of exposed group [ Time Frame: immediately after the frontline workers isolated for two weeks ]
    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.

  19. 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 ]
    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.

  20. The Symptom Check List 90 (SCL-90) of non-exposed group [ Time Frame: During the procedure of collecting faecal samples from 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.


Biospecimen Retention:   Samples With DNA
Gut microbiome DNA in faecal samples from included subjects will be extracted and sequnced for the statistical analysis.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
They are all medical staff in First Affiliated Hospital of Xi'an Jiaotong University
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04443075


Locations
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China, Shaanxi
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Principal Investigator: Xiancang Ma, M.D. First Affiliated Hospital Xi'an Jiaotong University
Publications:
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT04443075    
Other Study ID Numbers: XJTU1AF2020LSK-022
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders