Gut Microbiota and Metabonomics

N/AUnknownNCT05205187

First Hospital of China Medical University450 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

450

Conditions

Stomach Neoplasms Gut Microbiota Metabolomics

Interventions

Healthy control specimen collectionPROCEDURE

Collecting blood and feces from healthy population.

Non-Borrmann IV patient specimen collectionPROCEDURE

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

Borrmann IV patient specimen collectionPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (6)

The fourth People's Hospital of Changzhou

Changzhou, Jiangsu, China

RECRUITING

Chaoyang Central Hospital

Chaoyang, Liaoning, China

RECRUITING

The General Hospital of Fushun Mining Bureau

Fushun, Liaoning, China

Outcomes

Primary Outcomes

Participants' characteristics

To obtain participants' characteristics, including age, gender, alcohol consumption, body mass index, smoking, medications.

Time frame: 1 day

Microbial community structure

To assess participants' microbiome composition in faecal samples, inclding microbial diversity and richness.

Time frame: 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.

Time frame: 1 day

Microbes-metabolites correlations

To assess the correlations of gut microbiota and metabolites by Spearman's correlation analysis.

Time frame: 1 day

Response of target organ

To find the effects of microflora and metabolites on target organ by transcriptome sequencing.

Time frame: 1 day

Central Contacts

Kai Li, MD

CONTACT

8613998245233 cmu1h_likai@163.com

Data from ClinicalTrials.gov

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