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Status unknownNCT02833363Updated Oct 26, 2016

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

An observational study in Gastric Microbiota, Non-atrophic Gastritis and Atrophic Gastritis, sponsored by Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-26.

Sponsored by Shandong University · Observational

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Microbiota
  • Non-atrophic Gastritis
  • Atrophic Gastritis
  • Intestinal Metaplasia
  • Intraepithelial Neoplasia
  • Gastric Cancer
  • Helicobacter Pylori

Keywords

  • gastric microbiota
  • Helicobacter pylori
  • Non-atrophic Gasrititis
  • Atrophic gastritis
  • Intestinal metaplasia
  • intraepithelial neoplasia
  • Gastric cancer
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 50 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • patients with non-atrophic gastritis
  • Patients with gastritis
  • Patients with intestinal metaplasia
  • Patients with intrepithelial neoplasia
  • Patients with non-cardia gastric cancer
06

What researchers measure

Primary outcomes

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

    Time frame: 5 months

Secondary outcomes

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

    Time frame: 5 months

07

Study locations

1 of 1 sites recruiting
  • Department of Gastroenterology, Qilu Hospital, Shandong University
    Jinan, Shandong 250012, China
    • Yanqing Li, MD,PHD · Contact · liyanqing@sdu.edu.cn · 86-531-82169236
    • Yanqing Li, MD,PHD · Principal investigator
    • Tian Ma, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02833363
Lead sponsor
Shandong University
Responsible party
Yanqing Li (Vice president of Qilu Hospital, Shandong University) — Principal investigator
First posted
Jul 14, 2016
Start date
Jul 2016
Primary completion
Dec 2016 (estimated)
Completion
Feb 2017 (estimated)
Last update
Oct 26, 2016

Study contacts

Yanqing Li, MD,PHD
Contact
liyanqing@sdu.edu.cn
86-531-82169236
Yanqing Li, MD,PHD
principal investigator · Qilu Hospital of Shandong University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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