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

NCT ID: NCT04660058

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-20

Study Completion Date

2022-01-30

Brief Summary

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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

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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.

Conditions

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Bile Reflux Gastric Cancer Precancerous Lesion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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chronic gastritis

patients with chronic non-atrophic gastritis and chronic atrophic gastritis according to histopathological results

No interventions assigned to this group

precancerous lesion

patients with gastric intestinal metaplasia and intraepithelial neoplasia according to histopathological results

No interventions assigned to this group

gastric cancer

patients with gastric cancer according to histopathological results

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role lead

Responsible Party

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Yongquan Shi

Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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KY20202100-F-1

Identifier Type: -

Identifier Source: org_study_id

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