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Assessment of Small Intestinal Bowel Epithelial Gaps in Irritable Bowel Syndrome

NCT ID: NCT01632488

Last Updated: 2012-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-12-31

Brief Summary

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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

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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

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Irritable Bowel Syndrome Inflammatory Bowel Disease

Keywords

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Irritable Bowel Syndrome Inflammatory Bowel Disease Confocal Laser Endomicroscopy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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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

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, MD, PhD

Role: STUDY_DIRECTOR

Department of Gastroenterology, Qilu Hospital

Locations

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Facility: Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanqing Li, MD, PhD

Role: CONTACT

Phone: 86-531-8216923

Email: [email protected]

Facility Contacts

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Yanqing Li, MD, PhD

Role: primary

Other Identifiers

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2012SDU-QILU-G02

Identifier Type: -

Identifier Source: org_study_id