Association Between Inflammatory Activities and Gap Density

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01758926

Enrollment

Registered

2013-01-01

Start date

2012-12-31

Completion date

2013-06-30

Last updated

2013-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Keywords

Inflammatory Bowel Disease, Confocal Laser Endomicroscopy

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
gap density	6 months	the distributions of gap density

Secondary

Measure	Time frame	Description
local barrier function	6 months	the comparison local barrier function between the IBD group and normal control patients

Countries

China

Contacts

Primary ContactYanqing Li, MD, PhD

liyanqing@sdu.edu.cn86-531-8216923

Outcome results