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NCT Number: NCT06595095

The Correlation Characteristics Between Mental Health and Gut Microbiota of College Students in Qingyuan Vocational Education City

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhujiang hospital of southern medical university

Guangzhou, Guangdong, 510280, China

Location contact

Yan He, Professor

PRINCIPAL_INVESTIGATOR

Yumei Liu, Master

CONTACT

[email protected]

18810795365 ext. +86

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

1.Pregnant and Lactating Women.

Treatment and study plan

Primary outcomes

  1. Microbiota Characteristic Data

    Time frame: 2024.10-2025.9

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

Secondary outcomes

  1. general information of participants by questionnaire

    Time frame: 2024.10-2025.9

    The general information of participants will be collected through questionnaire, which includes demographic characteristics, disease history, gastrointestinal status, and lifestyle habits.

  2. Self-Rating Anxiety Scale SAS

    Time frame: 2024.10-2025.9

    Participants 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.

  3. Self-rating depression scale SDS

    Time frame: 2024.10-2025.9

    Participants 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.

  4. Pittsburgh sleep quality index PSQI

    Time frame: 2024.10-2025.9

    Participants 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yumei Liu, Master

CONTACT

[email protected]

18810795365

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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