Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia

Study Overview
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Brief Summary
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The aims of the investigators' study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.

Detailed Description
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Accumulating evidence shows that Helicobacter pylori protects against some metabolic and immunological diseases in which the development of these diseases coincide with temporal or permanent dysbiosis. Helicobacter pylori eradication therapy has the potential to improve symptoms of functional dyspepsia. The aims of our study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.

Official Title
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Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia

Conditions
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Dyspepsia

Intervention / Treatment
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* Drug: Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who has diagnosed with functional dyspesia by Rome IV criteria Exclusion Criteria: Known GI malignancy Previous Helicobater pylori eradication history Severe systemic disease Previous GI surgery Uncorrectable coagulopathy: INR > 1.5 or platelet < 50,000/ml Pregnant or breastfeeding women Atrophic gastritis, open type

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

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HP eradication group<br>HP eradication group Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days | Drug: Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days<br>* Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of gut microbiome | Change of gut microbiome at 3 months, and 6 months regardless of Helicobater positive or negative | at 3 months, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom of dyspepsia | Improvement of NDI-K, HADS,SEQ-FD at 3 and 6 months | at 3 months, and 6 months | 
| Eradication of helicobacter pylori | Eradication rate of helicobacter pylori at 3 months | at 3 months | 
| Histologic finding of UGI tract | Change of accumulationof inflammatory cells, eosinophils of esophagus, stomachm duodenal mucosal biopsy | at initial and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyspepsia, Microbiome, Eradication therapy