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

February 14, 2014 updated by: Yanqing Li, Shandong University
There might be a correlation between gastric mucosal microbiome and mucosal pattern visualized by confocal laser endomicroscope.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Department of Gastroenterology, Qilu Hospital, Shandong University
        • Sub-Investigator:
          • Ming Li, MD
        • Sub-Investigator:
          • wei wei, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
endomicroscopy
Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The operational taxonomy units in gastric mucosal microbiome
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The diagnostic accuracy of endomicroscopy compared to pathology.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Estimate)

February 17, 2014

Last Update Submitted That Met QC Criteria

February 14, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014SDU-QILU-G02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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