Gut Microbiota and Metabonomics

Stomach Neoplasms Clinical Trial

— MBS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05205187
• Other study ID #: Metabonomics
• Status: Recruiting
• Start date: February 28, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2022
• Source: First Hospital of China Medical University
• Contact: Kai Li, MD
• Phone: 8613998245233
• Email: cmu1h_likai[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gut Microbiota
• Metabolomics
• Stomach Neoplasms

Intervention

Procedure:
• Healthy control specimen collection
Collecting blood and feces from healthy population.
• Non-Borrmann IV patient specimen collection
Collecting blood, feces and gastric cancer tissues from Non-Borrmann IV patients.
• Borrmann IV patient specimen collection
Collecting blood, feces and gastric cancer tissues from Borrmann IV patients.

Locations

Country	Name	City	State
China	The fourth People's Hospital of Changzhou	Changzhou	Jiangsu
China	Chaoyang Central Hospital	Chaoyang	Liaoning
China	The General Hospital of Fushun Mining Bureau	Fushun	Liaoning
China	The Second Hospital of Shandong University	Ji'nan	Shandong
China	First Hospital of Jinzhou Medical University	Jinzhou	Liaoning
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning

Sponsors (6)

Lead Sponsor	Collaborator
First Hospital of China Medical University	Liaoning Cancer Hospital & Institute, The First People's Hospital of Jingzhou, The fourth People's Hospital of Changzhou, The General Hospital of Fushun Mining Bureau, The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

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