Assessment of Colonic Permeability by Confocal Laser Endomicroscopy

NCT00883077 | Unknown DMC

• 1 other identifier: 2009SDU-QILU-G01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of confocal laser endomicroscopy in assessment of colonic permeability against conventional sugar absorption test.

Conditions

Inflammatory Bowel Disease; Ulcerative Colitis; Irritable Bowel Syndrome

Keywords

permeability; inflammatory bowel disease; confocal laser endomicroscopy; irritable bowel syndrome

Outcome Measures

Primary Outcomes (1)

• Fluorescein leakage under confocal laser endomicroscopy observation of colonic mucosa.

  Within the 30 minutes after injection of fluorescein

Secondary Outcomes (1)

• Total sucralose excretion.

  Within the 24 hours after drinking of sucralose

Study Arms (3)

Inflammation

Patients with long standing history or short onset of ulcerative colitis.

Healthy controls

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

Irritable bowel syndrome

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

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 are the study population of this study.

You may qualify if:

• Patients with history of ulcerative colitis
• Bowel habits alterations meeting IBS diagnosis criteria and indications for colonoscopy investigation
• 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:

• Known cancers or abdominal surgery
• Scheduled for endoscopic treatment
• Alarm symptoms such as anaemia, gastrointestinal bleeding or obstruction, marked weight loss, abdominal mass
• Under conditions such as:
• ascites
• jaundice
• liver cirrhosis
• impaired renal function
• coagulopathy
• fever
• pregnancy
• breastfeeding
• Inability to provide informed consent
• Known allergy to fluorescein sodium

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biopsies during colonoscopy.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Yanqing Li, PhD. MD.

  Department of Gastroenterology, Qilu Hospital, Shandong University

  STUDY DIRECTOR

Central Study Contacts

Yanqing Li, PhD. MD.

CONTACT

86-531-8216923; qiluliyanqign@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 17, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 14, 2009

Record last verified: 2009-10

Locations

CN (1)