Association Between Confocal Laser Endomicroscopic (CLE) Features and Gastric Mucosal Microbiome

• Conditions: Intestinal Metaplasia; Mucosal Microbiome; Gastric Neoplasia; H.Pylori
• Interventions: Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencing

• Registration Number: NCT02063932
• Lead Sponsor: Shandong University

Brief Summary

There might be a correlation between gastric mucosal microbiome and mucosal pattern visualized by confocal laser endomicroscope.

Detailed Description

The gastric mucosal microbiome plays a pivotal role in a series of diseases, such as the H.pylori infection. We hypothesized that mucosal patterns, here visualized by confocal endomicroscopy, may constitute specific microbiome niches.

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-01
• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-02-14
• Last Update Submitted: 2014-02-14
• Study First Posted: 2014-02-17
• Last Update Posted: 2014-02-17
• Primary Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
endomicroscopy	endomicroscopy, targeted biopsy and 16s rRNA gene sequencing	-

Primary Outcome Measures

Name	Time	Method
The operational taxonomy units in gastric mucosal microbiome	6 months

Secondary Outcome Measures

Name	Time	Method
The diagnostic accuracy of endomicroscopy compared to pathology.	6 months

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China