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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lansoprazole+Clarithromycin+Amoxycillin | Experimental | Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprzole+Amoxicillin+Clarithromycin | Drug | Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Young Seol, Professor | Korean Society of Helicobacter and Upper Gastrointestinal Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korean Society of Helicobacter and Upper GI Research | Seoul | Seoul | 135-87 | South Korea |
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| 1 year |
| The adequate relief of symptom | 1 year |