Clinical trial NCT06595095: The Correlation Characteristics Between Mental Health and Gut Microbiota of College Students in Qingyuan Vocational Education City
Official title: The Correlation Characteristics Between Mental Health and Gut Microbiota of College Students in Qingyuan Vocational Education City
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Depression
Anxiety
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: College students aged 18-25 years old at Qingyuan Vocational Education City

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.


Eligibility criteria: Inclusion Criteria:

Healthy Individuals:

1. Ages 18 to 25 years old.
2. Resident in the local area for more than one month.
3. No obvious signs or symptoms of disease.
4. Good psychological condition.
5. College students currently enrolled in Qingyuan Vocational Education City.
6. Having signed an informed consent form, willing to provide relevant survey information and fecal samples.

Anxious Individuals:

1. Ages 18 to 25 years old.
2. Resident in the local area for more than one month.
3. Self-rating anxiety scale score greater than or equal to 50.
4. College students currently enrolled in Qingyuan Vocational Education City.
5. Having signed an informed consent form, willing to provide relevant survey information and fecal samples.

Depressive Individuals:

1. Ages 18 to 25 years old.
2. Resident in the local area for more than one month.
3. Self-rating depression scale score greater than or equal to 53.
4. College students currently enrolled in Qingyuan Vocational Education City.
5. Having signed an informed consent form, willing to provide relevant survey information and fecal samples.

Exclusion Criteria:

1.Pregnant and Lactating Women.

Primary outcomes:
measure: Microbiota Characteristic Data
timeFrame: 2024.10-2025.9
Secondary outcomes:
measure: general information of participants by questionnaire
timeFrame: 2024.10-2025.9
measure: Self-Rating Anxiety Scale SAS
timeFrame: 2024.10-2025.9
measure: Self-rating depression scale SDS
timeFrame: 2024.10-2025.9
measure: Pittsburgh sleep quality index PSQI
timeFrame: 2024.10-2025.9
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: