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

Intestinal Metaplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02063932
• Other study ID #: 2014SDU-QILU-G02
• Status: Recruiting
• Phase: N/A
• First received: January 29, 2014
• Last updated: February 14, 2014
• Start date: December 2013

Study information

• Verified date: January 2014
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• 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

• 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

• Gastric Neoplasia
• H.Pylori
• Intestinal Metaplasia
• 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 mucosal microbiome		6 months	No
Secondary	The diagnostic accuracy of endomicroscopy compared to pathology.		6 months	No