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

• Sponsor: Shandong University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02063919
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 6.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasia; Colorectal Inflammation; Hyperplasia; Mucosal Microbiome	Other: the mucosal microbiome in the biopsy specimen was analysed

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 Design

• Study Type: Observational
• Actual Enrollment: 45 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Association Between Confocal Laser Endomicroscopic (CLE) Features and Colorectal Mucosal Microbiome
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The operational taxonomy unit in the colorectal mucosal microbiome. [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong	China	250012

Sponsors and Collaborators

• Shandong University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
• ClinicalTrials.gov Identifier: NCT02063919
• Other Study ID Numbers: 2014SDU-QILU-G01
• First Posted: Feb 17, 2014
• Last Update Posted: Jun 30, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Inflammation; Hyperplasia

Study Results

No Results Posted as of Jun 30, 2015