Association Between Inflammatory Activities and Gap Density

Inflammatory Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01758926
• Other study ID #: 2012SDU-QILU-G03
• Status: Recruiting
• Phase: N/A
• First received: December 27, 2012
• Last updated: December 27, 2012
• Start date: December 2012
• Est. completion date: June 2013

Study information

• Verified date: December 2012
• Source: Shandong University
• Contact: Yanqing Li, MD, PhD
• Phone: 86-531-8216923
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

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	gap density	the distributions of gap density	6 months	No
Secondary	local barrier function	the comparison local barrier function between the IBD group and normal control patients	6 months	No