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

2014-08-27 03:18:51 | BioPortfolio

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.

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

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Functional Dyspepsia

Intervention

Lansoprzole+Amoxicillin+Clarithromycin

Location

Korean Society of Helicobacter and Upper GI Research
Seoul
Korea, Republic of
135-87

Status

Active, not recruiting

Source

Korean College of Helicobacter and Upper Gastrointestinal Research

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:51-0400

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Medical and Biotech [MESH] Definitions

A fixed-ratio combination of amoxicillin trihydrate (see AMOXICILLIN), an aminopenicillin, and potassium clavulanate (see CLAVULANIC ACID), a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.

A substituted benzamide used for its prokinetic properties. It is used in the management of gastroesophageal reflux disease, functional dyspepsia, and other disorders associated with impaired gastrointestinal motility. (Martindale The Extra Pharmacopoeia, 31st ed)

Impaired digestion, especially after eating.

A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.

A semisynthetic macrolide antibiotic derived from ERYTHROMYCIN that is active against a variety of microorganisms. It can inhibit protein synthesis in bacteria by reversibly binding to the 50S ribosomal subunits. This inhibits the translocation of aminoacyl transfer-RNA and prevents peptide chain elongation.

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