Mucosal Microbiome in Human Gastric Intestinal Metaplasia... | NCT02428426

Studies
Mucosal Microbiome in Human Gastric Intestinal Metaplasia and Duodenal Tissue.

NCT02428426

Sponsor

Shandong University

Status

Unknown status

Last Update Posted

Apr 28, 2015Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Mucosal Microbiome
Gastric Intestinal Metaplasia
Duodenum

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

Apr 2015

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

Sep 2014

Primary Completion Date

Jul 2015Estimated

Completion Date

Jul 2015Estimated

First Submitted Date

Apr 23, 2015

First Submission Date that Met QC Criteria

Apr 23, 2015

First Posted Date

Apr 28, 2015Estimated

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

Apr 23, 2015

Last Update Posted Date

Apr 28, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yanqing Li, Mucosal Microbiome in human gastric Intestinal Metaplasia and duodenal tissue., Shandong UniversityPrincipal Investigator

Lead Sponsor

Shandong UniversityOTHER

Collaborators

Not provided

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

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
gastric intestinal metaplasia		patients were diagnosed gastric intestinal metaplasia	Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencing
gastritis		patients were diagnosed non atrophic gastritis	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		gastric intestinal metaplasia gastritis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The operational taxonomy units in gastric Intestinal Metaplasia and and Duodenal mucosal microbiome		6 months

Secondary Outcomes

Not provided

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,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

Accepts Healthy Volunteers

Yes

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

Name	Role	Phone	Extension	Email
li yanqing, PhD,MD	Contact	86-531-82169236	82169508	liyanqing@sdu.edu.cn

Overall Officials

Name	Affiliation	Role
li yanqing, PhD,MD	Qilu Hospital of Shandong University	Principal Investigator

Locations

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