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NCT02063919 Clinical Trial

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

Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02063919
Other study ID # 2014SDU-QILU-G01
Secondary ID
Status Completed
Phase N/A
First received January 29, 2014
Last updated June 27, 2015
Start date November 2013
Est. completion date June 2014

Study information
Verified date June 2015
Source Shandong University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date June 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• the mucosal microbiome in the biopsy specimen was analysed

Locations
Country Name City State
China Department of Gastroenterology, Qilu Hospital, Shandong University Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The operational taxonomy unit in the colorectal mucosal microbiome. 6 months No
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