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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02833363
• Other study ID #: 2016SDU-QILU-08
• Status: Recruiting
• Phase: Phase 4
• First received: July 12, 2016
• Last updated: October 25, 2016
• Start date: July 2016
• Est. completion date: February 2017

Study information

• Verified date: October 2016
• Source: Shandong University
• Contact: Yanqing Li, MD,PHD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrophic Gastritis
• Atrophy
• Carcinoma in Situ
• Gastric Cancer
• Gastric Microbiota
• Gastritis
• Gastritis, Atrophic
• Helicobacter Pylori
• Intestinal Metaplasia
• Intraepithelial Neoplasia
• Metaplasia
• Neoplasms
• Non-atrophic Gastritis
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of Gastric Microbiota in the Process of Correa's Model.		5 months	No
Secondary	Difference of Gastric Microbiota in the Process of Correa's Model.		5 months	No