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Clinical Trials/NCT04660058
NCT04660058CompletedNot Applicable

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

Xijing Hospital of Digestive Diseases1 site in 1 country73 target enrollmentStarted: December 20, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
73
Locations
1
Primary Endpoint
corelation between the bile acid profile and gastric mucosa diseases

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

corelation between the bile acid profile and gastric mucosa diseases

Time Frame: 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

Time Frame: up to 6 months

Investigators explore the cross-talk between bile acid and gastric microbiota according to the results of 16s rRNA sequencing

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Xijing Hospital of Digestive Diseases
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yongquan Shi

Principal Investigator, Clinical Professor

Xijing Hospital of Digestive Diseases

Study Sites (1)

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