Investigation of the Detection Rate of Pathogenic Viruses in the Feces of Individuals With Non-gastrointestinal Infections

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.

Study Overview

• Status: Recruiting
• Conditions: Virus Infections

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Yumei Liu, master; Phone Number: +8618810795365; Email: liuyumei1007@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Recruiting
      • Zhujiang Hospital of Southern Medical University
      • Contact: Yumei Liu, master; Phone Number: +8618810795365; Email: liuyumei1007@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
apparently healthy individuals
parenteral virus infected patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
virus infection checklist	Viral infections in the respiratory system, digestive system, urinary system, cardiovascular system, etc.	2024.3-2025.12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
general information of apparently healthy individuals by questionnaire	The general information of participants will be collected through questionnaire, which includes demographic characteristics, disease and medical history, gastrointestinal status, dietary habits, and lifestyle habits.	2024.3-2025.12
demographic characteristics case information of parenteral virus infected patients	Investigators will retrospectively collect demographic characteristics and pathogen detection results of participants through case information.	2024.3-2025.12
Self-Rating Anxiety Scale SAS	Apparently healthy individuals will fill out this scale. The total score of the scale is 25-100. The cut-off value of SAS standard score is 50 points, with 50-59 points indicating mild anxiety, 60-69 points indicating moderate anxiety, and 69 points or above indicating severe anxiety.	2024.3-2025.12
Self-rating depression scale SDS	Apparently healthy individuals will fill out this scale. The total score of the scale is 25-100, with 53 points indicating normal, 53-62 points indicating mild depression, 63-72 points indicating moderate depression, and above 72 points indicating severe depression.	2024.3-2025.12
Pittsburgh sleep quality index PSQI	Apparently healthy individuals will fill out this scale. The total score of the scale is 0-21 points and can be divided into three levels. PSQI score ≤ 4 indicates good sleep quality, PSQI score ≤ 7 indicates average sleep quality, and PSQI score ≥ 8 indicates poor sleep quality (sleep disorders). Higher PSQI total scores indicate poorer sleep quality.	2024.3-2025.12

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Principal Investigator: Yan He, Doctor, Southern Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: zhujiangjy-20240229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No