Gut Microbiota and Metabonomics

NCT ID: NCT05205187

Last Updated: 2022-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-28

Study Completion Date

2025-12-31

Brief Summary

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To evaluate the correlation between gut microbiota and metabolites in Borrmann type IV gastric cancer; To find the effects of microflora and metabolites on target organs; To detect the mechanism of key flora and metabolite by in vitro and in vivo experiments; To construct models of gut microbiota and metabonomics by machine learning.

Detailed Description

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Conditions

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Stomach Neoplasms Gut Microbiota Metabolomics

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy group

Healthy people in the community.

Healthy control specimen collection

Intervention Type PROCEDURE

Collecting blood and feces from healthy population.

Non-Borrmann IV group

Patients with Borrmann types I, II and III gastric cancer.

Non-Borrmann IV patient specimen collection

Intervention Type PROCEDURE

Collecting blood, feces and gastric cancer tissues from Non-Borrmann IV patients.

Borrmann IV group

Patients with Borrmann type IV gastric cancer.

Borrmann IV patient specimen collection

Intervention Type PROCEDURE

Collecting blood, feces and gastric cancer tissues from Borrmann IV patients.

Interventions

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Healthy control specimen collection

Collecting blood and feces from healthy population.

Intervention Type PROCEDURE

Non-Borrmann IV patient specimen collection

Collecting blood, feces and gastric cancer tissues from Non-Borrmann IV patients.

Intervention Type PROCEDURE

Borrmann IV patient specimen collection

Collecting blood, feces and gastric cancer tissues from Borrmann IV patients.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients who sign informed consent.
2. Borrmann classification of gastric cancer is determined by more than 2 pathologists.
3. Patients with BMI 24-28.
4. Karnofsky (KPS) score \>80.

Exclusion Criteria

1. Patients who take any aspirin, antibiotics, prebiotics, or probiotics within 4 weeks and steroids or immunosuppressants within 6 months prior to specimen collection.
2. Patients who complicate with other malignant tumors.
3. Patients who complicate with diabetes, hypertension, heart disease and infectious diseases.
4. Patients who complicate with inflammatory bowel disease or irritable bowel syndrome.
5. Patients with metastasis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

The Second Hospital of Shandong University

OTHER

Sponsor Role collaborator

The General Hospital of Fushun Mining Bureau

UNKNOWN

Sponsor Role collaborator

The fourth People's Hospital of Changzhou

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Jingzhou

OTHER

Sponsor Role collaborator

First Hospital of China Medical University

OTHER

Sponsor Role lead

Responsible Party

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Kai Li

Deputy Director of surgical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kai Li, MD

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Locations

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The fourth People's Hospital of Changzhou

Changzhou, Jiangsu, China

Site Status RECRUITING

Chaoyang Central Hospital

Chaoyang, Liaoning, China

Site Status RECRUITING

The General Hospital of Fushun Mining Bureau

Fushun, Liaoning, China

Site Status ENROLLING_BY_INVITATION

First Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

Site Status RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status ACTIVE_NOT_RECRUITING

The Second Hospital of Shandong University

Ji'nan, Shandong, China

Site Status ENROLLING_BY_INVITATION

Countries

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China

Central Contacts

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Kai Li, MD

Role: CONTACT

8613998245233

Facility Contacts

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Yan Li

Role: primary

Shigang Guo

Role: primary

Yubin Wang

Role: primary

Other Identifiers

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Metabonomics

Identifier Type: -

Identifier Source: org_study_id

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