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Mucosal Barrier Defects in Functional Dyspepsia by Confocal Laser Endomicroscopy

Minimal Changes of Gastric Mucosal Barrier in the Pathophysiologic Mechanisms of Functional Dyspepsia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01006642
Enrollment
80
Registered
2009-11-03
Start date
2009-07-31
Completion date
2010-07-31
Last updated
2009-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia

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.

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).

Interventions

None listed

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Specific microscopic changes in the gastric mucosa as seen under the confocal endomicroscopeWithin the 30 minutes after injection of fluorescein

Secondary

MeasureTime frame
the relationship among minimal changes, FD symptoms , neuropeptides and immune responses.after the immunohistochemistry of biopsy

Countries

China

Contacts

Primary ContactYanqing Li, PhD. MD.
qiluliyanqign@gmail.com86-531-8216923

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026