Assessment of Small Intestinal Bowel Epithelial Gaps in Irritable Bowel Syndrome

June 28, 2012 updated by: Yanqing Li, Shandong University

Assessment of Small Intestinal Bowel Epithelial Gaps in Patients With Irritable Bowel Syndrome by Confocal Laser Endomicroscopy

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Facility: Department of Gastroenterology, Qilu Hospital, Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Irritable bowel syndrome
Patients admitted to outpatient department with symptoms meeting Rome III criteria of irritable bowel syndrome.
Inflammation
Patients with long standing history or short onset of inflammatory bowel disease.
Normal controls
Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Study Director: Yanqing Li, MD, PhD, Department of Gastroenterology, Qilu Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

June 28, 2012

First Submitted That Met QC Criteria

June 28, 2012

First Posted (Estimate)

July 3, 2012

Study Record Updates

Last Update Posted (Estimate)

July 3, 2012

Last Update Submitted That Met QC Criteria

June 28, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012SDU-QILU-G02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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