Gut Microbiota and Metabonomics

Study Overview
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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.

Official Title
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Multi-center and Multi-omics Mechanism Research of Gut Microbiota and Metabonomics in Borrmann Type IV Gastric Cancer

Conditions
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Stomach Neoplasms, Gut Microbiota, Metabolomics

Intervention / Treatment
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* Procedure: Healthy control specimen collection
* Procedure: Non-Borrmann IV patient specimen collection
* Procedure: Borrmann IV patient specimen collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who sign informed consent. Borrmann classification of gastric cancer is determined by more than 2 pathologists. Patients with BMI 24-28. Karnofsky (KPS) score >80. Exclusion Criteria: Patients who take any aspirin, antibiotics, prebiotics, or probiotics within 4 weeks and steroids or immunosuppressants within 6 months prior to specimen collection. Patients who complicate with other malignant tumors. Patients who complicate with diabetes, hypertension, heart disease and infectious diseases. Patients who complicate with inflammatory bowel disease or irritable bowel syndrome. Patients with metastasis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy group<br>Healthy people in the community. | Procedure: Healthy control specimen collection<br>* Collecting blood and feces from healthy population.<br>|
| Non-Borrmann IV group<br>Patients with Borrmann types I, II and III gastric cancer. | Procedure: Non-Borrmann IV patient specimen collection<br>* Collecting blood, feces and gastric cancer tissues from Non-Borrmann IV patients.<br>|
| Borrmann IV group<br>Patients with Borrmann type IV gastric cancer. | Procedure: Borrmann IV patient specimen collection<br>* Collecting blood, feces and gastric cancer tissues from Borrmann IV patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' characteristics | To obtain participants' characteristics, including age, gender, alcohol consumption, body mass index, smoking, medications. | 1 day | 
| Microbial community structure | To assess participants' microbiome composition in faecal samples, inclding microbial diversity and richness. | 1 day | 
| Metabolite composition | 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. | 1 day | 
| Microbes-metabolites correlations | To assess the correlations of gut microbiota and metabolites by Spearman's correlation analysis. | 1 day | 
| Response of target organ | To find the effects of microflora and metabolites on target organ by transcriptome sequencing. | 1 day |