NCT06595095

Brief Summary

The goal of this observational study is to learn about the mental health status and gut microbiota characteristics of college students in Qingyuan Vocational Education City. The main question it aims to answer is: How is the mental condition of college students in Qingyuan Vocational Education City? Is there a correlation between the mental condition and the microbial characteristics of college students in Qingyuan Vocational Education City? Participants will answer online survey questions about their demographic characteristics, disease history, gastrointestinal status, lifestyle habits, and psychological health information. 200 participants from each of the following groups will be included: healthy individuals, anxious Individuals and depressive Individuals. Fecal samples will be collected for microbiome testing and analysis to obtain their microbial characteristics and to analyze the impact of mental health status on microbial changes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

September 10, 2024

Last Update Submit

September 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Microbiota Characteristic Data

    The characteristics of microbiota include composition, abundance, and diversity, etc.

    2024.10-2025.9

Secondary Outcomes (4)

  • general information of participants by questionnaire

    2024.10-2025.9

  • Self-Rating Anxiety Scale SAS

    2024.10-2025.9

  • Self-rating depression scale SDS

    2024.10-2025.9

  • Pittsburgh sleep quality index PSQI

    2024.10-2025.9

Study Arms (3)

Healthy individuals

Anxious Individuals

Depressive Individuals

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

College students aged 18-25 years old at Qingyuan Vocational Education City

You may qualify if:

  • Healthy Individuals:
  • Ages 18 to 25 years old.
  • Resident in the local area for more than one month.
  • No obvious signs or symptoms of disease.
  • Good psychological condition.
  • College students currently enrolled in Qingyuan Vocational Education City.
  • Having signed an informed consent form, willing to provide relevant survey information and fecal samples.
  • Anxious Individuals:
  • Ages 18 to 25 years old.
  • Resident in the local area for more than one month.
  • Self-rating anxiety scale score greater than or equal to 50.
  • College students currently enrolled in Qingyuan Vocational Education City.
  • Having signed an informed consent form, willing to provide relevant survey information and fecal samples.
  • Depressive Individuals:
  • Ages 18 to 25 years old.
  • +4 more criteria

You may not qualify if:

  • Pregnant and Lactating Women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang hospital of southern medical university

Guangzhou, Guangdong, 510280, China

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

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
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

May 31, 2025

Study Completion

September 10, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations