Association Between Confocal Laser Endomicroscopic (CLE)... | NCT02063932

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

NCT02063932

Sponsor

Shandong University

Status

Unknown status

Last Update Posted

Feb 17, 2014Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Mucosal Microbiome
H.Pylori
Intestinal Metaplasia
Gastric Neoplasia

Interventions

endomicroscopy, targeted biopsy and 16s rRNA gene sequencing

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Jun 2014Estimated

Completion Date

Not provided

First Submitted Date

Jan 29, 2014

First Submission Date that Met QC Criteria

Feb 14, 2014

First Posted Date

Feb 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2014

Last Update Posted Date

Feb 17, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
endomicroscopy			Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endomicroscopy, targeted biopsy and 16s rRNA gene sequencing	Other		endomicroscopy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology, Qilu Hospital, Shandong University	Recruiting	Jinan	Shandong	250012	China