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

April 6, 2021 updated by: Yongquan Shi, Xijing Hospital of Digestive Diseases

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

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

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hosipital of Digestive Disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients are from Xijing Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
chronic gastritis
patients with chronic non-atrophic gastritis and chronic atrophic gastritis according to histopathological results
precancerous lesion
patients with gastric intestinal metaplasia and intraepithelial neoplasia according to histopathological results
gastric cancer
patients with gastric cancer according to histopathological results

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
up to 6 months
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
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital of Digestive Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2020

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20202100-F-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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