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

NCT ID: NCT02063919

Last Updated: 2015-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Colorectal Neoplasia Colorectal Inflammation Hyperplasia Mucosal Microbiome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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endomicroscopy

the mucosal microbiome in the biopsy specimen was analysed

Intervention Type OTHER

Interventions

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the mucosal microbiome in the biopsy specimen was analysed

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, PhD., MD.

Role: PRINCIPAL_INVESTIGATOR

Department of gastroenterology, Qilu Hospital, Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2014SDU-QILU-G01

Identifier Type: -

Identifier Source: org_study_id