NCT02428426

Brief Summary

To investigate the mucosal microbiome in human gastric intestinal etaplasia and duodenal tissue.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

10 months

First QC Date

April 23, 2015

Last Update Submit

April 23, 2015

Conditions

Mucosal MicrobiomeGastric Intestinal MetaplasiaDuodenum

Keywords

Mucosal Microbiomegastric intestinal metaplasiaduodenum

Outcome Measures

Primary Outcomes (1)

  • The operational taxonomy units in gastric Intestinal Metaplasia and and Duodenal mucosal microbiome

    6 months

Study Arms (2)

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

endomicroscopy, targeted biopsy and 16s rRNA gene sequencingOTHER
gastric intestinal metaplasiagastritis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients scheduled for gastroendoscopy examination Aged between 18 and 80 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The metagenome was obtained from biopsy specimen.

Study Officials

  • li yanqing, PhD,MD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

li yanqing, PhD,MD

CONTACT

86-531-82169236liyanqing@sdu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mucosal Microbiome in human gastric Intestinal Metaplasia and duodenal tissue.

Study Record Dates

First Submitted

April 23, 2015

First Posted

April 28, 2015

Study Start

September 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

CN(1)