Mucosal Barrier Defects in Functional Dyspepsia by Confocal Laser Endomicroscopy

Functional Dyspepsia Clinical Trial

Official title:

Minimal Changes of Gastric Mucosal Barrier in the Pathophysiologic Mechanisms of Functional Dyspepsia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01006642
• Other study ID #: 2009SDU-QILU-G04
• Status: Recruiting
• Phase: N/A
• First received: November 2, 2009
• Last updated: November 2, 2009
• Start date: July 2009
• Est. completion date: July 2010

Study information

• Verified date: November 2009
• Source: Shandong University
• Contact: Yanqing Li, PhD. MD.
• Phone: 86-531-8216923
• Email: qiluliyanqign[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

There has been recent interest into the potential role of mucosal barrier defects in the pathophysiology of functional gastrointestinal disorders (FGIDs). There has been evidence of increased intestinal permeability in patients of IBS,and abnormal tissue resistance in NERD. Although the mucosa of Functional dyspepsia (FD) patients is endoscopically and histologically "normal," it contains ultrastructural changes, activated immune cells, along with evidence of an increased release of mediators leading to gastric dysfunction. There is now consistent evidence indicating that mucosal barrier defects allow the passage of an increased load of bacteria, antigens and toxins which, in turn evoke activation of mucosal immune responses involved in the FD symptom.

Description:

Confocal laser endomicrosopy is a newly developed device which allows in vivo and real time observation of gastrointestinal mucosa.In our pilot study we found that the contrast agent fluorescein sodium shew differences of leakage into intercellular spaces and crypt lumen among different patients of FD.

This study is aimed to determine if there is microscopic changes detectable in the gastric mucosal epithelium through confocal endomicroscopy of FD patients, and to evaluate the relationship among minimal changes(transmission electron microscopy and Confocal laser endomicrosopy ), FD symptoms(symptom index form) , neuropeptides and immune responses(immunohistochemistry).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients meeting IBS diagnosis criteria and indications for endoscopy investigation.

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

Exclusion Criteria:

• Esophageal, gastric or duodenal cancer or other malignancy

• History of esophagus, stomach, or duodenum surgery

• Conditions that preclude safe biopsies (coagulopathy, haemophilia, esophageal varices,and patients on warfarin and antiplatelets)

• A history of bronchial asthma, or known allergy to fluorescein

• Pregnant or breast-feeding (for females)

• Below 18 or above 75 years of age

• Severe co-morbidities

• Unable or unwilling to give informed consent

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific microscopic changes in the gastric mucosa as seen under the confocal endomicroscope		Within the 30 minutes after injection of fluorescein	No
Secondary	the relationship among minimal changes, FD symptoms , neuropeptides and immune responses.		after the immunohistochemistry of biopsy	No