Assessment of Small Intestinal Bowel Epithelial Gaps in Irritable Bowel Syndrome

NCT ID: NCT01632488

Last Updated: 2012-07-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-12-31

Brief Summary

The study aims to:

1. Determine whether the density of epithelial gaps in terminal ileum of patients with irritable bowel syndrome (IBS) is different from that in inflammatory bowel disease (IBD) patients and normal controls by confocal laser endomicroscopy (CLE).

2. Evaluate the relationship between the density of epithelial gaps and IBS subtypes, and visceral hypersensitivity.

Detailed Description

Epithelial cells lining the gastrointestinal tract serve as a barrier between the gut lumen and the body. Previous study has shown that epithelium is punctuated by discontinuities named "gaps". Confocal laser endomicroscopy could be used as a useful tool for detecting epithelial gaps in vivo, and epithelial gap density in terminal ileum of IBD patients was elevated compared with normal control using CLE. So this study aims to determine whether the density of epithelial gaps in terminal ileum of patients with IBS is different from that in IBD patients and normal controls by CLE, and to evaluate the relationship between the density of epithelial gaps and IBS subtypes, and visceral hypersensitivity.

Conditions

Irritable Bowel Syndrome; Inflammatory Bowel Disease

Study Design

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

Study Groups

Irritable bowel syndrome

Patients admitted to outpatient department with symptoms meeting Rome III criteria of irritable bowel syndrome.

No interventions assigned to this group

Inflammation

Patients with long standing history or short onset of inflammatory bowel disease.

No interventions assigned to this group

Normal controls

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Bowel habits alterations meeting IBS Rome III criteria and indications for colonoscopy investigation
• Patients with history of inflammatory bowel disease
• Asymptomatic individuals for health surveillance or patients for follow up after polypectomy
• Patients complained of hemafecia but colonoscopy revealed only haemorrhoid

Exclusion Criteria

• Patients with known cancers or abdominal surgery
• Alarm symptoms such as anaemia, gastrointestinal bleeding or obstruction, marked weight loss, abdominal mass
• Patients who are unwilling to sign or give the informed consent form
• Patients who are allergic to fluorescein sodium
• Patients with impaired cardiac, liver or renal function
• Patients with coagulopathy
• Patients with pregnancy or breastfeeding

• 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

Facility: 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-G02

Identifier Type: -

Identifier Source: org_study_id