Association Between Confocal Laser Endomicroscopic (CLE)... | NCT02063919

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

NCT02063919

Sponsor

Shandong University

Status

Completed

Last Update Posted

Jun 30, 2015Estimated

Enrollment

45Actual

Phase

Not provided

Conditions

Colorectal Neoplasia
Colorectal Inflammation
Hyperplasia
Mucosal Microbiome

Interventions

the mucosal microbiome in the biopsy specimen was analysed

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Apr 2014Actual

Completion Date

Jun 2014Actual

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

Jun 27, 2015

Last Update Posted Date

Jun 30, 2015Estimated

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

The purpose of this study is to determine whether an association between endomicroscopic pattern and colorectal mucosal microbiome exists.

Detailed Description

The gut microbiome plays a pivotal role in the intestinal pathophysiology. The mucosal microbiome is in the front face of microbiome-host cross-talk. Confocal laser endomicroscopy (CLE) can provide realtime mucosal images during ongoing endoscopy. We hypothesized that the mucosal pattern, here evaluated by endomicroscopy, may constitute specific microbiome niches and participate the evolvement of the mucosal microbiome.

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

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
endomicroscopy			Other: the mucosal microbiome in the biopsy specimen was analysed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
the mucosal microbiome in the biopsy specimen was analysed	Other		endomicroscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The operational taxonomy unit in the colorectal mucosal microbiome.		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years old ≤ age < 80 years old
Scheduled for colonoscopy in Qilu Hospital

Exclusion Criteria:

antibiotic usage within 2 months
probiotic or prebiotic usage within 2 months
ascites
jaundice
liver cirrhosis
impaired renal function
coagulopathy
fever
pregnancy
breastfeeding
inability to provide informed consent
known allergy to fluorescein sodium

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

Patients with indications for colonoscopy in Qilu Hospital outpatient and inpatient department are the study population of this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yanqing Li, PhD., MD.	Department of gastroenterology, Qilu Hospital, Shandong University	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D006965	Hyperplasia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided