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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04660058
• Other study ID #: KY20202100-F-1
• Status: Completed
• Start date: December 20, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: January 2023
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: January 30, 2022
• Est. primary completion date: December 30, 2021
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bile Reflux
• Gastric Cancer
• Precancerous Lesion
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Xijing Hosipital of Digestive Disease	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

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