Mucosal Barrier Defects in Functional Dyspepsia by Confocal Laser Endomicroscopy
|ClinicalTrials.gov Identifier: NCT01006642|
Recruitment Status : Unknown
Verified November 2009 by Shandong University.
Recruitment status was: Recruiting
First Posted : November 3, 2009
Last Update Posted : November 3, 2009
|Condition or disease|
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|
|Estimated Enrollment :||80 participants|
|Observational Model:||Case Control|
|Official Title:||Minimal Changes of Gastric Mucosal Barrier in the Pathophysiologic Mechanisms of Functional Dyspepsia|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||March 2010|
|Estimated Study Completion Date :||July 2010|
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
- Specific microscopic changes in the gastric mucosa as seen under the confocal endomicroscope [ Time Frame: Within the 30 minutes after injection of fluorescein ]
- the relationship among minimal changes, FD symptoms , neuropeptides and immune responses. [ Time Frame: after the immunohistochemistry of biopsy ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|