Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

648 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2010-12-31

Brief Summary

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patients who had failed previous H. pylori eradication on standard triple therapy were randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d) (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests were performed with 13C urea breath test (UBT) or invasive tests (Giemsa histology, CLO test, and culture). In patients who maintained continuous H. pylori negativity for the first year after eradication therapy, H. pylori status was assessed every year. For the evaluation of risk factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or intestinal metaplasia were analyzed.

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Detailed Description

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Conditions

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Helicobacter Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MEA

MEA: moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.)

Group Type ACTIVE_COMPARATOR

esomeprazole

Intervention Type DRUG

moxifloxacin

Intervention Type DRUG

amoxicillin

Intervention Type DRUG

EBMT

EBMT: esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d)

Group Type ACTIVE_COMPARATOR

esomeprazole

Intervention Type DRUG

tripotassium dicitrate bismuthate

Intervention Type DRUG

metronidazole

Intervention Type DRUG

tetracycline

Intervention Type DRUG

Interventions

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esomeprazole

Intervention Type DRUG

tripotassium dicitrate bismuthate

Intervention Type DRUG

metronidazole

Intervention Type DRUG

tetracycline

Intervention Type DRUG

moxifloxacin

Intervention Type DRUG

amoxicillin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients were considered persistent H. pylori infection if 13C-urea breath test (UBT) or invasive H. pylori test (Giemsa histology, CLO test, culture) were positive despite PPI-based triple therapy.

Exclusion Criteria

* Patients were excluded from the study if they had a history of renal or hepatic impairment, previous gastric surgery, pregnancy or lactation, therapy with steroids or non-steroidal anti-inflammatory drugs, or therapy with a proton pump inhibitor (PPI) or antibiotics within four weeks of entry.

Minimum Eligible Age

23 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No