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

Sponsor
Shandong University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02833363
Collaborator
(none)
50
1
7.1
7.1

Study Details

Study Description

Brief Summary

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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Difference of Gastric Microbiota in the Process of Correa's Model.
Study Start Date :
Jul 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Feb 1, 2017

Arms and Interventions

Arm Intervention/Treatment
patients with non-atrophic gastritis

Patients with gastritis

Patients with intestinal metaplasia

Patients with intrepithelial neoplasia

Patients with non-cardia gastric cancer

Outcome Measures

Primary Outcome Measures

  1. Difference of Gastric Microbiota in the Process of Correa's Model. [5 months]

Secondary Outcome Measures

  1. Difference of Gastric Microbiota in the Process of Correa's Model. [5 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Gastroenterology, Qilu Hospital, Shandong University Jinan Shandong China 250012

Sponsors and Collaborators

  • Shandong University

Investigators

  • Principal Investigator: Yanqing Li, MD,PHD, Qilu Hospital of Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yanqing Li, Vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier:
NCT02833363
Other Study ID Numbers:
  • 2016SDU-QILU-08
First Posted:
Jul 14, 2016
Last Update Posted:
Oct 26, 2016
Last Verified:
Oct 1, 2016

Study Results

No Results Posted as of Oct 26, 2016