Gastric Barrier Dysfunction of Functional Dyspepsia and Therapeutic Response to Puyuanhewei Detected by Endomicroscopy

Study Overview
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Brief Summary
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Functional dyspepsia might have impaired gastric mucosal dysfunction and Puyuanhewei may be helpful to improve the symptoms of FD.

Detailed Description
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This study aimed to investigate the gastric mucosal dysfunction in functional dyspepsia (FD) and verify the efficacy of Puyuanhewei for treating FD and assess the relationship between gastric microalterations and therapeutic response by endomicroscopy.

Official Title
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Gastric Barrier Dysfunction of Functional Dyspepsia and Therapeutic Response to Puyuanhewei Detected by Endomicroscopy

Conditions
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Dyspepsia

Intervention / Treatment
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* Device: pCLE examination
* Drug: Puyuanhewei


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive outpatients aged 18 to 75 years old. FD patients defined by the Rome III classification. Willing to choose pCLE and no organic diseases. Exclusion Criteria: Severe liver, heart, or kidney diseases. Current or past evidence of uncontrolled diabetes mellitus, psychosomatic disorders, such as depressive and anxiety disorders, and drug or alcohol abuse. Pregnant or breastfeeding women. Inability to give informed consent. Use of nonsteroidal anti-inflammatory drugs, proton pump inhibitors, H2-receptor antagonists, antacids, prokinetics, or other injurious drugs (antibiotics, and steroids) in the prior two weeks.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: postprandial distress syndrome (PDS)<br>FD patients fulfilled Rome III criteria were subclassified into postprandial distress syndrome (PDS) or epigastric pain syndrome (EPS). pCLE examination was performed in PDS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination. | Device: pCLE examination<br>* All FD patients received pCLE examination.<br>* Other names: prob-based confocal laser endomicroscopy examination;Drug: Puyuanhewei<br>* FD patients willing to receive Puyuanhewei were given 4 pills three times a day regardless of PDS or EPS for 4 weeks after pCLE examination.<br>* Other names: Puyanhewei capsule administration;|
| Other: epigastric pain syndrome (EPS)<br>pCLE examination was performed in EPS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination. | Device: pCLE examination<br>* All FD patients received pCLE examination.<br>* Other names: prob-based confocal laser endomicroscopy examination;Drug: Puyuanhewei<br>* FD patients willing to receive Puyuanhewei were given 4 pills three times a day regardless of PDS or EPS for 4 weeks after pCLE examination.<br>* Other names: Puyanhewei capsule administration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pCLE score | Used to assess the gastric barrier dysfunction of FD patients | within 1 hour after pCLE examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leeds dyspepsia questionaire | Used to describe the change of severity of FD from baseline to the 4th week during the treatment | baseline and 4th week | 
| Main dyspepsia symptom score | Used to describe the change of severity and frequency of despepsia symptoms from baseline to the 4th week during the treatment | baseline and 4th weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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barrier dysfunction, Confocal Laser Endomicroscopic, functional dyspepsia, therapeutic response