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Association Between Inflammatory Activities and Gap Density

Sponsor
Shandong University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01758926
Collaborator
(none)
50
Enrollment
1
Location
6
Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Association Between Inflammatory Activities and Epithelial Gap Density in Inflammatory Bowel Disease
    Study Start Date :
    Dec 1, 2012
    Anticipated Primary Completion Date :
    Jun 1, 2013
    Anticipated Study Completion Date :
    Jun 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Inflammatory bowel disease

    Patients previously diagnosed as having IBD
    Health control

    Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy.

    Outcome Measures

    Primary Outcome Measures

    1. gap density [6 months]

      the distributions of gap density

    Secondary Outcome Measures

    1. local barrier function [6 months]

      the comparison local barrier function between the IBD group and normal control patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    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

    • Study Director: Yanqing Li, MD, PhD, Department of Gastroenterology, Qilu Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yanqing Li, Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University, Shandong University
    ClinicalTrials.gov Identifier:
    NCT01758926
    Other Study ID Numbers:
    • 2012SDU-QILU-G03
    First Posted:
    Jan 1, 2013
    Last Update Posted:
    Jan 1, 2013
    Last Verified:
    Dec 1, 2012
    Keywords provided by Yanqing Li, Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University, Shandong University
    Inflammatory Bowel Disease
    Confocal Laser Endomicroscopy
    Additional relevant MeSH terms:
    Intestinal Diseases
    Inflammatory Bowel Diseases

    Study Results

    No Results Posted as of Jan 1, 2013