NCT04443075: AGMFMSS

Alterations of Gut Microbiome in the Frontline Medical Staff Under the Stress

Completed Last updated 3 March 2021

What this trial tests

trial testing faecal sample collector in Stress Disorders, Post-Traumatic in 180 participants. Completed in 24 December 2020.

Timeline

24 June 2020

Primary endpoint
4 December 2020

24 December 2020

Quick facts

Lead sponsor	First Affiliated Hospital Xi'an Jiaotong University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	180
Start date	24 June 2020
Primary completion	4 December 2020
Estimated completion	24 December 2020
Sites	1 location across China

Drugs / interventions tested

• faecal sample collector

Conditions studied

• Stress Disorders, Post-Traumatic — all drugs for Stress Disorders, Post-Traumatic →

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Who can join

Adults 18 to 50, any sex, with Stress Disorders, Post-Traumatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lost microbes of COVID-19: <i>Bifidobacterium</i>, <i>Faecalibacterium</i> depletion and decreased microbiome diversity associated with SARS-CoV-2 infection severity.
   Hazan S, Stollman N, Bozkurt HS, Dave S, et al · · 2022 · cited 66× · PMID 35483736 · DOI 10.1136/bmjgast-2022-000871
2. Stressful events induce long-term gut microbiota dysbiosis and associated post-traumatic stress symptoms in healthcare workers fighting against COVID-19.
   Gao F, Guo R, Ma Q, Li Y, et al · · 2022 · cited 53× · PMID 35157946 · DOI 10.1016/j.jad.2022.02.024
3. The lost microbes of COVID-19: Bifidobacterium, Faecalibacterium depletion and decreased microbiome diversity associated with SARS-CoV-2 infection severity
   Hazan S, Stollman N, Bozkurt H, Dave S, et al · · 2021 · DOI 10.1101/2021.09.02.21262832