Assessment of Small Intestinal Bowel Epithelial Gaps in Irritable Bowel Syndrome

NCT01632488 | Unknown DMC

• 1 other identifier: 2012SDU-QILU-G02
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to:

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

Conditions

Irritable Bowel Syndrome; Inflammatory Bowel Disease

Keywords

Irritable Bowel Syndrome; Inflammatory Bowel Disease; Confocal Laser Endomicroscopy

Study Arms (3)

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.

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Facility: Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Taken biopsies during endoscopy

MeSH Terms

Conditions

Irritable Bowel Syndrome; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

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: June 28, 2012
• First Posted: July 3, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 3, 2012

Record last verified: 2012-06

Locations

CN (1)