Association Between Inflammatory Activities and Epithelial Gap Density in Inflammatory Bowel Disease

Shandong University1 site in 1 country50 target enrollmentDecember 2012

ConditionsInflammatory Bowel Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Inflammatory Bowel Disease
Sponsor: Shandong University
Enrollment: 50
Locations: 1
Primary Endpoint: gap density
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study aims to:

To determine the relationship between inflammatory activities and epithelial gaps in IBD by CLE and evaluate epithelial gaps healing via dexamethasone treatment.
To demonstrated the alteration of local barrier function in IBD using CLE.

Detailed Description

The primary end-point of this study was the cohort comparison of epithelial gap density and local barrier function as determined by CLE of subjects with IBD versus controls. Despite discontinuities in the cellular layer, the intestinal barrier function is maintained during this high cell turnover rate at the apical pole of the epithelial layer. Gaps first identified in vivo through acriflavine have pivotal definitions (lacked nuclei or cytosol, appeared to be filled with an impermeable substance). However, Current endoscopic technology does not identify whether there is material present in human gaps, so investigators could not formally resolve whether human epithelial gaps compromise or defend the epithelial barrier.

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

June 2013

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shandong University

Responsible Party

Principal Investigator

Yanqing Li

Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University

Shandong University

Eligibility Criteria

Inclusion Criteria

•Male or Female aged 18-80
•IBD： Patients previously diagnosed as having IBD
•Health control: Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy.
•Subjects who experienced successful intubation of the terminal ileum.

Exclusion Criteria

•Subjects age \< 18 or \>80 years
•Subjects under conditions unsuitable for performing CLE including coagulopathy (prothrombin time \<50% of control, partial thromboplastin time \>50 s), cirrhosis, renal dysfunction (creatinine level \>1.2 mg/dL), pregnancy or breastfeeding, acute gastrointestinal bleeding, jaundice and known allergy to fluorescein sodium.