NCT02063932

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 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

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Last Updated

February 17, 2014

Status Verified

January 1, 2014

Enrollment Period

6 months

First QC Date

January 29, 2014

Last Update Submit

February 14, 2014

Conditions

Mucosal MicrobiomeH.PyloriIntestinal MetaplasiaGastric Neoplasia

Keywords

mucosal microbiomeH.pyloriintestinal metaplasiagastric neoplasiaendomicroscopy

Outcome Measures

Primary Outcomes (1)

  • The operational taxonomy units in gastric mucosal microbiome

    6 months

Secondary Outcomes (1)

  • The diagnostic accuracy of endomicroscopy compared to pathology.

    6 months

Study Arms (1)

endomicroscopy

Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencing

Interventions

endomicroscopy, targeted biopsy and 16s rRNA gene sequencingOTHER
endomicroscopy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
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
  • 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 Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

January 29, 2014

First Posted

February 17, 2014

Study Start

December 1, 2013

Primary Completion

June 1, 2014

Last Updated

February 17, 2014

Record last verified: 2014-01

Locations

CN(1)