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Association Between Inflammatory Activities and Gap Density

This study is currently recruiting participants.
Verified December 2012 by Shandong University
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University
ClinicalTrials.gov Identifier:
NCT01758926
First received: December 27, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Association Between Inflammatory Activities and Epithelial Gap Density in Inflammatory Bowel Disease

Further study details as provided by Shandong University:

Primary Outcome Measures:
  • gap density [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    the distributions of gap density


Secondary Outcome Measures:
  • local barrier function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    the comparison local barrier function between the IBD group and normal control patients


Biospecimen Retention:   Samples With DNA

Observational Study Model: Case-Control


Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Inflammatory bowel disease
Patients previously diagnosed as having IBD
Health control
Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with indications for colonoscopy in Qilu Hospital outpatient and inpatient department.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758926

Contacts
Contact: Yanqing Li, MD, PhD 86-531-8216923 ext 82169508 liyanqing@sdu.edu.cn

Locations
China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yanqing Li, MD, PhD     86-531-82169236 ext 82169508     liyanqing@sdu.edu.cn    
Sponsors and Collaborators
Shandong University
Investigators
Study Director: Yanqing Li, MD, PhD Department of Gastroenterology, Qilu Hospital
  More Information

No publications provided

Responsible Party: Yanqing Li, Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University, Shandong University
ClinicalTrials.gov Identifier: NCT01758926     History of Changes
Other Study ID Numbers: 2012SDU-QILU-G03
Study First Received: December 27, 2012
Last Updated: December 27, 2012
Health Authority: China: Ministry of Health

Keywords provided by Shandong University:
Inflammatory Bowel Disease
Confocal Laser Endomicroscopy

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013