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

Korean College of Helicobacter and Upper Gastrointestinal Research

Status and phase: Unknown; Phase 4

Conditions: Functional Dyspepsia; Helicobacter Pylori Infection

Treatments: Drug: Lansoprzole+Amoxicillin+Clarithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00990405

KoreanCHUGR05

Details and patient eligibility

About

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.

Full description

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

Enrollment: 400 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 1 patient group

Lansoprazole+Clarithromycin+Amoxycillin

Experimental group

Description:

Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days

Treatment:

Drug: Lansoprzole+Amoxicillin+Clarithromycin