Associations Among Serum and Gastric Juice Bile Acid Profile, Bile Acid-microbiota Cross-talk in Stomach and the Development of Gastric Cancer

Completed

• Conditions: Bile Reflux; Gastric Cancer; Precancerous Lesion

• Registration Number: NCT04660058
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief Summary

To explore the associations among bile acid profile, bile acid-microbiota cross-talk and the development of gastric cancer, so as to better prevent the occurrence and development of gastric cancer

Detailed Description

This study is a case-control study. Patients, according to the pathological results, will be consecutively enrolled and divided into gastric cancer group, gastric precancerous lesions group, and chronic gastritis group. The serum and gastric juice bile acid profiles, gastric microbial composition of each group patients will be detected.

Study Timeline

• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-09
• Study Start: 2020-12-20
• Primary Completion: 2021-12-30
• Study Completion: 2022-01-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-29
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

1. Age 18 to 75 years old, gender is not limited;
2. No history of antibiotic or probiotic use for 8 weeks;
3. No preoperative chemotherapy or radiation therapy prior to the examination;
4. Voluntary intravenous blood collection, gastroscopy, extraction of gastric juice and pathological biopsy.
5. Voluntary testing for H. pylori

Exclusion Criteria

1. had undergone upper gastrointestinal and colon surgery;
2. Previous diagnosis of Malignant Tumors;
3. Presence of a disease or medication that affects bile acid metabolism, such as endocrine or autoimmune diseases;
4. Recent use of drugs that affect gastrointestinal motility;
5. Presence of contraindications to endoscopy;
6. pregnant and lactating women;
7. Those with mental disorders;
8. Refusal to sign the informed consent form.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
corelation between the bile acid profile and gastric mucosa diseases	up to 6 months	Investigators evaluate the corelation between the bile acid profile and gastric mucosa diseases according to the results of UPLC-MS/MS and pathological .
corelation between the bile acid profile and gastric microbiota in different groups	up to 6 months	Investigators explore the cross-talk between bile acid and gastric microbiota according to the results of 16s rRNA sequencing

Trial Locations

Locations (1)

Xijing Hosipital of Digestive Disease; 🇨🇳 Xi'an, Shaanxi, China