Difference of Gastric Microbiota in the Process of Correa's Model.

October 25, 2016 updated by: Yanqing Li, Shandong University
Helicobater pylori plays an important role in the development of gastric cancer. Eradication therapy can reducing the morbidity of gastric cancer, but can't totally prevent it especially when atrophy and more serious precancerous lesions already happened. Prior studies found the gastric bacterial difference among gastritis, intestinal metaplasia and gastric cancer. However, they didn't reach an agreement. Correa's model is widely accepted in the development of gastric cancer. The pathological change makes a more suitable environment for bacteria to overgrowth. This study are designed to analyze the gastric microbial difference of non-atrophic gastritis, atrophic gastritis, intestinal metaplasia, intraepithelial neoplasia and gastric cancer.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

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
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Department of Gastroenterology, Qilu Hospital, Shandong University
        • Contact:
        • Principal Investigator:
          • Yanqing Li, MD,PHD
        • Sub-Investigator:
          • Tian Ma, MD

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients go through a gastric endoscopy examination with non-atrophic gastritis, atrophic gastris, intestinal metaplasia, intraepithelial neoplasia and gastric cancer.

Description

Inclusion Criteria:

  1. Patients go through a gastric endoscopy examination with non-atrophic gastritis, atrophic gastris, intestinal metaplasia, intraepithelial neoplasia and gastric cancer.
  2. Did not take any antibiotics,PPI,probiotics and chinese herbs in the past one month,and took less than one week in the past three months before the gastroscopy examination.
  3. Sign the informed consent.

Exclusion Criteria:

  1. Had been taken Helicobacter pylori eradication therapy before.
  2. Previous gastrointestinal surgery.
  3. During the pregnancy and lactation period.
  4. With any serious diseases like liver failure,heart failure,renal failure,malignant tumor,alcoholism or any other disease that may effect the result.
  5. With any mental problems.

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
patients with non-atrophic gastritis
Patients with gastritis
Patients with intestinal metaplasia
Patients with intrepithelial neoplasia
Patients with non-cardia gastric cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference of Gastric Microbiota in the Process of Correa's Model.
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference of Gastric Microbiota in the Process of Correa's Model.
Time Frame: 5 months
5 months

Collaborators and Investigators

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

Sponsor

Shandong University

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

July 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016SDU-QILU-08

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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