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

Recruiting

• Conditions: Virus Infections

• Registration Number: NCT06367647
• Lead Sponsor: Zhujiang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Study Start: 2024-05-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
virus infection checklist	2024.3-2025.12	Viral infections in the respiratory system, digestive system, urinary system, cardiovascular system, etc.

Secondary Outcome Measures

Name	Time	Method
Self-rating depression scale SDS	2024.3-2025.12	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.
general information of apparently healthy individuals by questionnaire	2024.3-2025.12	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.
demographic characteristics case information of parenteral virus infected patients	2024.3-2025.12	Investigators will retrospectively collect demographic characteristics and pathogen detection results of participants through case information.
Self-Rating Anxiety Scale SAS	2024.3-2025.12	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.
Pittsburgh sleep quality index PSQI	2024.3-2025.12	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.

Trial Locations

Locations (1)

Zhujiang hospital of southern medical university; 🇨🇳 Guangzhou, Guangdong, China