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Mucosal Barrier Defects in Functional Dyspepsia by Confocal Laser Endomicroscopy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Shandong University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01006642
First Posted: November 3, 2009
Last Update Posted: November 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shandong University
  Purpose
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.

Condition
Functional Dyspepsia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Minimal Changes of Gastric Mucosal Barrier in the Pathophysiologic Mechanisms of Functional Dyspepsia

Resource links provided by NLM:


Further study details as provided by Shandong University:

Primary Outcome Measures:
  • Specific microscopic changes in the gastric mucosa as seen under the confocal endomicroscope [ Time Frame: Within the 30 minutes after injection of fluorescein ]

Secondary Outcome Measures:
  • the relationship among minimal changes, FD symptoms , neuropeptides and immune responses. [ Time Frame: after the immunohistochemistry of biopsy ]

Biospecimen Retention:   Samples With DNA
Biopsies during endoscopy

Estimated Enrollment: 80
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)
Groups/Cohorts
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006642


Contacts
Contact: Yanqing Li, PhD. MD. 86-531-8216923 qiluliyanqign@gmail.com

Locations
China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yanqing Li, PhD. MD.    86-531-82169236 ext 82169508    qiluliyanqing@gmail.com   
Contact: Rui Ji, MD.    86-531-88396062 ext 82169328    jirui905@gmail.com   
Principal Investigator: Yanqing Li, PhD. MD.         
Sub-Investigator: Rui Ji, MD.         
Sponsors and Collaborators
Shandong University
Investigators
Study Director: Yanqing Li, PhD. MD. Department of Gastroenterology, Qilu Hospital
  More Information

Responsible Party: Yan-Qing Li, Department of Gastroenterology, Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT01006642     History of Changes
Other Study ID Numbers: 2009SDU-QILU-G04
First Submitted: November 2, 2009
First Posted: November 3, 2009
Last Update Posted: November 3, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases


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