Association Between Inflammatory Activities and Gap Density

• Conditions: Inflammatory Bowel Disease

• Registration Number: NCT01758926
• Lead Sponsor: Shandong University

Brief Summary

The study aims to:

1. To determine the relationship between inflammatory activities and epithelial gaps in IBD by CLE and evaluate epithelial gaps healing via dexamethasone treatment.

2. 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.

Study Timeline

• Status Verified: 2012-12
• Study Start: 2012-12
• Study First Submitted: 2012-12-27
• Study First Submitted QC: 2012-12-27
• Last Update Submitted: 2012-12-27
• Study First Posted: 2013-01-01
• Last Update Posted: 2013-01-01
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
gap density	6 months	the distributions of gap density

Secondary Outcome Measures

Name	Time	Method
local barrier function	6 months	the comparison local barrier function between the IBD group and normal control patients

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China