Mucosal Microbiome in Human Gastric Intestinal Metaplasia and Duodenal Tissue.

Gastric Intestinal Metaplasia Clinical Trial

Official title:

Mucosal Microbiome in Human Gastric Intestinal Metaplasia and Duodenal Tissue.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02428426
• Other study ID #: 2015SDU-QILU-G04
• Status: Recruiting
• Phase: N/A
• First received: April 23, 2015
• Last updated: April 23, 2015
• Start date: September 2014
• Est. completion date: July 2015

Study information

• Verified date: April 2015
• Source: Shandong University
• Contact: li yanqing, PhD,MD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

To investigate the mucosal microbiome in human gastric intestinal etaplasia and duodenal tissue.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for gastroendoscopy examination Aged between 18 and 80 years old

Exclusion Criteria:

• Antibiotic, probiotic or prebiotic usage within 2months,gastric inhibitor usage within 1 month Esophageal, gastric or duodenal cancer or other malignancy History of upper GI tract surgery Coagulopathy or bleeding disorders Allergy to fluorescein sodium Pregnant or breast-feeding (for females) Impaired renal function

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Duodenum
• Gastric Intestinal Metaplasia
• Gastritis, Atrophic
• Metaplasia
• Mucosal Microbiome

Intervention

Other:
• endomicroscopy, targeted biopsy and 16s rRNA gene sequencing

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	The operational taxonomy units in gastric Intestinal Metaplasia and and Duodenal mucosal microbiome		6 months	No