Mucosal Barrier Defects in Functional Dyspepsia by Confocal Laser Endomicroscopy

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

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.

Study Overview

• Status: Unknown
• Conditions: Functional Dyspepsia

Detailed 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).

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Department of Gastroenterology, Qilu Hospital, Shandong University
      • Contact: Yanqing Li, PhD. MD.; Phone Number: 82169508 86-531-82169236; Email: qiluliyanqing@gmail.com
      • Principal Investigator: Yanqing Li, PhD. MD.
      • Contact: Rui Ji, MD.; Phone Number: 82169328 86-531-88396062; Email: jirui905@gmail.com
      • Sub-Investigator: Rui Ji, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with indications for upper-endoscopy in Qilu Hospital outpatient and inpatient department are the study population of this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy controls; Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy.
Functional dyspepsia-EPS; Functional dyspepsia-EPS(epigastric pain syndrome) Patients admitted to outpatient department with symptoms meeting ROME III criteria
Functional dyspepsia-PDS; Functional dyspepsia-PDS(postprandial distress syndrome) Patients admitted to outpatient department with symptoms meeting ROME III criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Specific microscopic changes in the gastric mucosa as seen under the confocal endomicroscope	Within the 30 minutes after injection of fluorescein

Secondary Outcome Measures

Outcome Measure	Time Frame
the relationship among minimal changes, FD symptoms , neuropeptides and immune responses.	after the immunohistochemistry of biopsy

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Study Director: Yanqing Li, PhD. MD., Department of Gastroenterology, Qilu Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): March 1, 2010
• Study Completion (Anticipated): July 1, 2010

Study Registration Dates

• First Submitted: November 2, 2009
• First Submitted That Met QC Criteria: November 2, 2009
• First Posted (Estimate): November 3, 2009

Study Record Updates

• Last Update Posted (Estimate): November 3, 2009
• Last Update Submitted That Met QC Criteria: November 2, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: 2009SDU-QILU-G04