Clinical trial NCT06367647: Investigation of the Detection Rate of Pathogenic Viruses in the Feces of Individuals With Non-gastrointestinal Infections
Official title: Investigation of the Detection Rate of Pathogenic Viruses in the Feces of Individuals With Non-gastrointestinal Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Virus Infections
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: virus infection checklist
timeFrame: 2024.3-2025.12
Secondary outcomes:
measure: general information of apparently healthy individuals by questionnaire
timeFrame: 2024.3-2025.12
measure: Self-Rating Anxiety Scale SAS
timeFrame: 2024.3-2025.12
measure: Self-rating depression scale SDS
timeFrame: 2024.3-2025.12
measure: Pittsburgh sleep quality index PSQI
timeFrame: 2024.3-2025.12
measure: demographic characteristics case information of parenteral virus infected patients
timeFrame: 2024.3-2025.12
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang hospital of southern medical university
state: Guangdong
Study officials:
affiliation: Southern Medical University, China
name: Yan He, Doctor
role: PRINCIPAL_INVESTIGATOR
References: