DepressionNCT06595095
The Correlation Characteristics Between Mental Health and Gut Microbiota of College Students in Qingyuan Vocational Education City
An observational study of Depression and Anxiety, run by Zhujiang Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 10 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: College students aged 18-25 years old at Qingyuan Vocational Education City
Who may be able to join
- 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.
Show all 19Show fewer
- 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.
Who cannot join
- 1.Pregnant and Lactating Women.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhujiang hospital of southern medical university
Guangzhou, Guangdong, 510280
Yumei Liu, Master, 18810795365 ext. +86, liuyumei1007@163.com
Yan He, Professor
About this study
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.
- Conditions
- Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Not described | |
| Anxious Individuals | Not described | |
| Depressive Individuals | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota Characteristic Data
The characteristics of microbiota include composition, abundance, and diversity, etc.
Measured: 2024.10-2025.9
Secondary outcomes (4)
general information of participants by questionnaire
The general information of participants will be collected through questionnaire, which includes demographic characteristics, disease history, gastrointestinal status, and lifestyle habits.
Measured: 2024.10-2025.9
Self-Rating Anxiety Scale SAS
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.
Measured: 2024.10-2025.9
Self-rating depression scale SDS
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.
Measured: 2024.10-2025.9
Pittsburgh sleep quality index PSQI
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.
Measured: 2024.10-2025.9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan He, Zhujiang Hospital
- Investigators
- Yan He, Doctor, Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595095
- Sponsor's protocol ID
- zhujiangjy-20240701
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Characteristics Between Mental Health and Gut Microbiota of College Students in Qingyuan Vocational Education City
- ClinicalTrials.gov ID
- NCT06595095
- Acronym / sponsor ID
- zhujiangjy-20240701
- Conditions
- Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | – |
| Anxious Individuals | – | – |
| Depressive Individuals | – | – |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- College students aged 18-25 years old at Qingyuan Vocational Education City
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (1 listed)
- 1.Pregnant and Lactating Women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbiota Characteristic Data
Time frame: 2024.10-2025.9
The characteristics of microbiota include composition, abundance, and diversity, etc.
4 secondary outcomes
general information of participants by questionnaire
Time frame: 2024.10-2025.9
Self-Rating Anxiety Scale SAS
Time frame: 2024.10-2025.9
Self-rating depression scale SDS
Time frame: 2024.10-2025.9
Pittsburgh sleep quality index PSQI
Time frame: 2024.10-2025.9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan He, Doctor principal investigator
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yumei Liu, Master (18810795365, liuyumei1007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota Characteristic Data (time frame: 2024.10-2025.9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.