Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia

Study Overview
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Brief Summary
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The role of Helicobacter pylori infection in functional dyspepsia remains controversial. Several randomized controlled trials in western countries have shown no significant advantage over placebo. But some recent studies in Asian population were different compared to the result of studies in the Western population. At the present time, it seems to be difficult to conclude the efficacy of the H.pylori eradication therapy in patients with H. pylori-infected functional dyspepsia. The investigators hypothesize that eradication of Helicobacter pylori has a sustained global symptom improvement in patients with H. pylori infected functional dyspepsia.

Detailed Description
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Functional dyspepsia: diagnosed by Rome III criteria of Functional gastrointestinal disorder Treatment regimen: Combination of proton pump inhibitor, Amoxicillin, Clarithromycin for 7 days Placebo: Same shaped placebo drugs

Official Title
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Phase 4 Study of Helicobacter Pylori Eradication Therapy

Conditions
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Functional Dyspepsia, Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Lansoprzole+Amoxicillin+Clarithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Functional dyspepsia by Rome III criteria Normal endoscopic findings H. pylori positive by Urea breath test Exclusion Criteria: Patients with severe concomitant systemic disease Patients with GI surgery Females with pregnancy or breast-feeding Irritable bowel syndrome, inflammatory bowel disease Duodenal Ulcer, Gastric Ulcer, GI bleeding History of eradication therapy of Helicobacter pylori Malignancy Psychosomatic disease

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lansoprazole+Clarithromycin+Amoxycillin<br>Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days | Drug: Lansoprzole+Amoxicillin+Clarithromycin<br>* Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy) |  | Symptom assessment at 8 weeks after eradication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To improves the quality of life |  | 1 year | 
| Global symptom improvement, at 4 weeks after Helicobacter pylori eradication therapy |  | 1 year | 
| The improvement of 8 dyspeptic symptom |  | 1 year | 
| The adequate relief of symptom |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rome III criteria