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Completed

NCT Number: NCT04660058

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

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

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 .

  2. 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

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 9, 2020
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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