Gut Microbiota and Metabonomics

Recruiting

• Conditions: Gut Microbiota; Metabolomics; Stomach Neoplasms
• Interventions: Procedure: Healthy control specimen collection; Procedure: Non-Borrmann IV patient specimen collection; Procedure: Borrmann IV patient specimen collection

• Registration Number: NCT05205187
• Lead Sponsor: First Hospital of China Medical University

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-11
• Last Update Submitted: 2022-01-11
• Study First Posted: 2022-01-25
• Last Update Posted: 2022-01-25
• Study Start: 2022-02-28
• Primary Completion: 2024-01-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy group	Healthy control specimen collection	Healthy people in the community.
Non-Borrmann IV group	Non-Borrmann IV patient specimen collection	Patients with Borrmann types I, II and III gastric cancer.
Borrmann IV group	Borrmann IV patient specimen collection	Patients with Borrmann type IV gastric cancer.

Primary Outcome Measures

Name	Time	Method
Participants' characteristics	1 day	To obtain participants' characteristics, including age, gender, alcohol consumption, body mass index, smoking, medications.
Microbial community structure	1 day	To assess participants' microbiome composition in faecal samples, inclding microbial diversity and richness.
Metabolite composition	1 day	To measure the metabolite profiles in participants' faecal samples and serum samples, involving Bile acids, short chain fatty acids, TMAO and related metabolites, amino acids, fatty acids, organic acids, flavonoids, plant hormones, neurotransmitters.
Microbes-metabolites correlations	1 day	To assess the correlations of gut microbiota and metabolites by Spearman's correlation analysis.
Response of target organ	1 day	To find the effects of microflora and metabolites on target organ by transcriptome sequencing.

Trial Locations

Locations (6)

The General Hospital of Fushun Mining Bureau; 🇨🇳 Fushun, Liaoning, China

The fourth People's Hospital of Changzhou; 🇨🇳 Changzhou, Jiangsu, China

The Second Hospital of Shandong University; 🇨🇳 Ji'nan, Shandong, China

The First Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

First Hospital of Jinzhou Medical University; 🇨🇳 Jinzhou, Liaoning, China

Chaoyang Central Hospital; 🇨🇳 Chaoyang, Liaoning, China