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

June 27, 2015 updated by: Yanqing Li, Shandong University
The purpose of this study is to determine whether an association between endomicroscopic pattern and colorectal mucosal microbiome exists.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
endomicroscopy
Other: the mucosal microbiome in the biopsy specimen was analysed

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Principal Investigator: Yanqing Li, PhD., MD., Department of Gastroenterology, Qilu Hospital, Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Estimate)

June 30, 2015

Last Update Submitted That Met QC Criteria

June 27, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014SDU-QILU-G01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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