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Functional Dyspepsia | Mucosal Barrier Defects in Functional Dyspepsia by Confocal Laser Endomicroscopy

Functional Dyspepsia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Functional Dyspepsia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Healthy controlsAsymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy.

Functional dyspepsia-EPSFunctional dyspepsia-EPS(epigastric pain syndrome) Patients admitted to outpatient department with symptoms meeting ROME III criteria

Functional dyspepsia-PDSFunctional dyspepsia-PDS(postprandial distress syndrome) Patients admitted to outpatient department with symptoms meeting ROME III criteria

Study Status

Unknown status

Start Date: July 2009

Completed Date: July 2010

Phase:

Type: Observational

Design:

Primary Outcome: Specific microscopic changes in the gastric mucosa as seen under the confocal endomicroscope

Secondary Outcome: the relationship among minimal changes, FD symptoms , neuropeptides and immune responses.

Study sponsors, principal investigator, and references

Principal Investigator: Yanqing Li, PhD. MD.

Lead Sponsor: Shandong University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01006642

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