Association Between Inflammatory Activities and Gap Density

NCT01758926 | Unknown DMC

• 1 other identifier: 2012SDU-QILU-G03
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to:

1. 1.To determine the relationship between inflammatory activities and epithelial gaps in IBD by CLE and evaluate epithelial gaps healing via dexamethasone treatment.
2. 2.To demonstrated the alteration of local barrier function in IBD using CLE.

Conditions

Inflammatory Bowel Disease

Keywords

Inflammatory Bowel Disease; Confocal Laser Endomicroscopy

Outcome Measures

Primary Outcomes (1)

• gap density

  the distributions of gap density

  6 months

Secondary Outcomes (1)

• local barrier function

  6 months

Study Arms (2)

Inflammatory bowel disease

Patients previously diagnosed as having IBD

Health control

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Observational Study Model: Case-Control

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Yanqing Li, MD, PhD

  Department of Gastroenterology, Qilu Hospital

  STUDY DIRECTOR

Central Study Contacts

Yanqing Li, MD, PhD

CONTACT

86-531-8216923; liyanqing@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University

Study Record Dates

• First Submitted: December 27, 2012
• First Posted: January 1, 2013
• Study Start: December 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 1, 2013

Record last verified: 2012-12

Locations

CN (1)