Mucosal Barrier Defects in Functional Dyspepsia by Confocal Laser Endomicroscopy

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. 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
Information provided by:
Shandong University

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.

Condition or disease
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
Estimated Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

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

Primary Outcome Measures :
  1. 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 :
  1. 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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

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

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 identifier (NCT number): NCT01006642

Contact: Yanqing Li, PhD. MD. 86-531-8216923

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

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

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