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

NCT ID: NCT02833363

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients with non-atrophic gastritis

No interventions assigned to this group

Patients with gastritis

No interventions assigned to this group

Patients with intestinal metaplasia

No interventions assigned to this group

Patients with intrepithelial neoplasia

No interventions assigned to this group

Patients with non-cardia gastric cancer

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shandong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yanqing Li, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yanqing Li, MD,PHD

Role: CONTACT

Phone: 86-531-82169236

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yanqing Li, MD,PHD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016SDU-QILU-08

Identifier Type: -

Identifier Source: org_study_id