Clinical trial NCT01006642: Mucosal Barrier Defects in Functional Dyspepsia by Confocal Laser Endomicroscopy
Official title: Minimal Changes of Gastric Mucosal Barrier in the Pathophysiologic Mechanisms of Functional Dyspepsia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional Dyspepsia
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2009-11-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Specific microscopic changes in the gastric mucosa as seen under the confocal endomicroscope
timeFrame: Within the 30 minutes after injection of fluorescein
Secondary outcomes:
measure: the relationship among minimal changes, FD symptoms , neuropeptides and immune responses.
timeFrame: after the immunohistochemistry of biopsy
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital
name: Yanqing Li, PhD. MD.
role: STUDY_DIRECTOR
References: