Mucosal Barrier Defects in Functional Dyspepsia by Confocal Laser Endomicroscopy
Recruitment status was Recruiting
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 Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Minimal Changes of Gastric Mucosal Barrier in the Pathophysiologic Mechanisms of Functional Dyspepsia|
- Specific microscopic changes in the gastric mucosa as seen under the confocal endomicroscope [ Time Frame: Within the 30 minutes after injection of fluorescein ] [ Designated as safety issue: No ]
- the relationship among minimal changes, FD symptoms , neuropeptides and immune responses. [ Time Frame: after the immunohistochemistry of biopsy ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Biopsies during endoscopy
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||July 2010|
|Estimated Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy.
Functional dyspepsia-EPS(epigastric pain syndrome) Patients admitted to outpatient department with symptoms meeting ROME III criteria
Functional dyspepsia-PDS(postprandial distress syndrome) Patients admitted to outpatient department with symptoms meeting ROME III criteria
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006642
|Contact: Yanqing Li, PhD. MD.||firstname.lastname@example.org|
|Department of Gastroenterology, Qilu Hospital, Shandong University||Recruiting|
|Jinan, Shandong, China, 250012|
|Contact: Yanqing Li, PhD. MD. 86-531-82169236 ext 82169508 email@example.com|
|Contact: Rui Ji, MD. 86-531-88396062 ext 82169328 firstname.lastname@example.org|
|Principal Investigator: Yanqing Li, PhD. MD.|
|Sub-Investigator: Rui Ji, MD.|
|Study Director:||Yanqing Li, PhD. MD.||Department of Gastroenterology, Qilu Hospital|