NCT06367647

Brief Summary

This project is a cross-sectional study. Investigators plan to search and collect 1600 publicly published fecal metagenomic and metatranscriptome data through the Pubmed database, by summarizing and analyzing them to construct an enterovirus database. 200 apparently healthy individuals are planned to be enrolled. At the time of enrollment, fecal specimens of participants will be collected, and their demographic characteristics, disease and medication history, gastrointestinal status, dietary habits, lifestyle habits, and mental health information will be recorded. Another 200 specimens will be collected from patients with parenteral virus infection. The demographic characteristics and pathogen test results of the parenteral virus infected patients will be reviewed and recorded. By virus metagenomic sequencing on fecal specimens, investigators will identify which viruses can be detected in the intestinal tract of apparently healthy people, and to explore whether parenteral infection viruses can be detected in feces.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

May 4, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

1.5 years

First QC Date

April 11, 2024

Last Update Submit

June 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • virus infection checklist

    Viral infections in the respiratory system, digestive system, urinary system, cardiovascular system, etc.

    2024.3-2025.12

Secondary Outcomes (5)

  • general information of apparently healthy individuals by questionnaire

    2024.3-2025.12

  • Self-Rating Anxiety Scale SAS

    2024.3-2025.12

  • Self-rating depression scale SDS

    2024.3-2025.12

  • Pittsburgh sleep quality index PSQI

    2024.3-2025.12

  • demographic characteristics case information of parenteral virus infected patients

    2024.3-2025.12

Study Arms (2)

apparently healthy individuals

parenteral virus infected patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Apparent healthy people are those who do not have clinically obvious symptoms and signs, but may have underlying health problems or premorbid conditions.

You may qualify if:

  • age ranged from 18 to 75 years;
  • no obvious symptoms and signs of the disease;
  • not taking a drug for a long time;
  • good psychological condition ;
  • no unhealthy lifestyle;
  • willing to participate in the study, sign the informed consent, fill out the questionnaire and provide fecal samples.

You may not qualify if:

  • pregnant and lactating women;
  • suffering from certain diseases, such as cardiovascular disease, digestive system disease and nervous system disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang hospital of southern medical university

Guangzhou, Guangdong, 510280, China

RECRUITING

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Yan He, Doctor

    Southern Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yumei Liu, master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 11, 2024

First Posted

April 16, 2024

Study Start

May 4, 2024

Primary Completion

October 31, 2025

Study Completion

December 31, 2025

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations