The Correlation Characteristics Between Mental Health and... | NCT06595095

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

NCT06595095

Sponsor

Zhujiang Hospital

Status

Not yet recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Depression
Anxiety

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Estimated

Primary Completion Date

May 31, 2025Estimated

Completion Date

Sep 10, 2025Estimated

First Submitted Date

Sep 10, 2024

First Submission Date that Met QC Criteria

Sep 10, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Microbiota Characteristic Data	The characteristics of microbiota include composition, abundance, and diversity, etc.	2024.10-2025.9

Secondary Outcomes

Measure	Description	Time Frame
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.	2024.10-2025.9
Self-Rating Anxiety Scale SAS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yumei Liu, Master	Contact	18810795365		liuyumei1007@163.com

Overall Officials

Name	Affiliation	Role
Yan He, Doctor	Southern Medical University, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhujiang hospital of southern medical university		Guangzhou	Guangdong	510280	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003863	Depression
D001008	Anxiety Disorders

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders

Label	Type	Description	Intervention Names
Healthy individuals
Anxious Individuals
Depressive Individuals