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Assessment of Small Intestinal Bowel Epithelial Gaps in Irritable Bowel Syndrome

This study is currently recruiting participants.
Verified June 2012 by Shandong University
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University
ClinicalTrials.gov Identifier:
NCT01632488
First received: June 28, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.

Condition
Irritable Bowel Syndrome
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Small Intestinal Bowel Epithelial Gaps in Patients With Irritable Bowel Syndrome by Confocal Laser Endomicroscopy

Further study details as provided by Shandong University:

Biospecimen Retention:   Samples With DNA

Taken biopsies during endoscopy


Estimated Enrollment: 45
Study Start Date: June 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632488

Contacts
Contact: Yanqing Li, MD, PhD 86-531-8216923 ext 82169508 liyanqing@sdu.edu.cn

Locations
China, Shandong
Facility: Department of Gastroenterology, Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yanqing Li, MD, PhD     86-531-82169236 ext 82169508     liyanqing@sdu.edu.cn    
Sponsors and Collaborators
Shandong University
Investigators
Study Director: Yanqing Li, MD, PhD Department of Gastroenterology, Qilu Hospital
  More Information

No publications provided

Responsible Party: Yanqing Li, Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University, Shandong University
ClinicalTrials.gov Identifier: NCT01632488     History of Changes
Other Study ID Numbers: 2012SDU-QILU-G02
Study First Received: June 28, 2012
Last Updated: June 28, 2012
Health Authority: China: Ministry of Health

Keywords provided by Shandong University:
Irritable Bowel Syndrome
Inflammatory Bowel Disease
Confocal Laser Endomicroscopy

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Irritable Bowel Syndrome
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases, Functional
Colonic Diseases

ClinicalTrials.gov processed this record on May 23, 2013