Association Between Inflammatory Activities and Gap Density

NCT ID: NCT01758926

Last Updated: 2013-01-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-06-30

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.

Conditions

Inflammatory Bowel Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Inflammatory bowel disease

Patients previously diagnosed as having IBD

No interventions assigned to this group

Health control

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

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Yanqing Li

Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanqing Li, MD, PhD

Role: STUDY_DIRECTOR

Department of Gastroenterology, Qilu Hospital

Locations

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanqing Li, MD, PhD

Role: CONTACT

liyanqing@sdu.edu.cn

86-531-8216923 ext. 82169508

Facility Contacts

Yanqing Li, MD, PhD

Role: primary

liyanqing@sdu.edu.cn

86-531-82169236 ext. 82169508

Other Identifiers

2012SDU-QILU-G03

Identifier Type: -

Identifier Source: org_study_id