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Gut Microbiota and Metabonomics

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05205187
Acronym
MBS
Enrollment
450
Registered
2022-01-25
Start date
2022-02-28
Completion date
2025-12-31
Last updated
2022-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiota, Metabolomics, Stomach Neoplasms

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.

Interventions

PROCEDUREHealthy control specimen collection

Collecting blood and feces from healthy population.

PROCEDURENon-Borrmann IV patient specimen collection

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

PROCEDUREBorrmann IV patient specimen collection

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

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Participants' characteristics1 dayTo obtain participants' characteristics, including age, gender, alcohol consumption, body mass index, smoking, medications.
Microbial community structure1 dayTo assess participants' microbiome composition in faecal samples, inclding microbial diversity and richness.
Metabolite composition1 dayTo 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 correlations1 dayTo assess the correlations of gut microbiota and metabolites by Spearman's correlation analysis.
Response of target organ1 dayTo find the effects of microflora and metabolites on target organ by transcriptome sequencing.

Countries

China

Contacts

Primary ContactKai Li, MD
cmu1h_likai@163.com8613998245233

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026