Exploring gut bacteria and metabolites in gastric cancer

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

This study is trying to see how gut bacteria and their byproducts affect people with a specific type of stomach cancer compared to healthy individuals and those with other types of stomach cancer.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: First Hospital of China Medical University (Academic / other)
• Locations: 6 sites (Changzhou, Jiangsu and 5 other locations)
• Trial ID: NCT05205187 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the relationship between gut microbiota and metabolites in patients with Borrmann type IV gastric cancer. It will involve collecting specimens from healthy controls, non-Borrmann IV patients, and Borrmann IV patients to analyze the effects of microflora and metabolites on target organs. Additionally, the study will utilize in vitro and in vivo experiments to uncover the mechanisms of key flora and metabolites, and will employ machine learning to construct models of gut microbiota and metabonomics.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with Borrmann type IV gastric cancer who meet specific health criteria.

Not a fit: Patients with other malignant tumors, significant comorbidities, or those currently taking certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of gastric cancer and lead to improved diagnostic and therapeutic strategies.

How similar studies have performed: While the approach of correlating gut microbiota with cancer metabolites is gaining interest, this specific study's methodology appears to be novel and untested.

Eligibility criteria

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.

Where this trial is running

Changzhou, Jiangsu and 5 other locations

• 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 (Enrolling_by_invitation)
• First Hospital of Jinzhou Medical University — Jinzhou, Liaoning, China (Recruiting)
• The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Active_not_recruiting)
• The Second Hospital of Shandong University — Ji'nan, Shandong, China (Enrolling_by_invitation)

Study contacts

• Principal investigator: Kai Li, MD — First Hospital of China Medical University
• Study coordinator: Kai Li, MD

Conditions Stomach Neoplasms; Gut Microbiota; Metabolomics