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

Phase 4 Study of Helicobacter Pylori Eradication Therapy

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00990405

Enrollment

400

Registered

2009-10-06

Start date

2009-10-31

Completion date

2010-12-31

Last updated

2009-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia, Helicobacter Pylori Infection

Keywords

Rome III criteria

Brief summary

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

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

Interventions

DRUGLansoprzole+Amoxicillin+Clarithromycin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy)	Symptom assessment at 8 weeks after eradication

Secondary

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026