Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication

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

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-01-31

Brief Summary

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No trial has examined the the efficacy of amoxicillin and metronidazole based quadruple therapy for Helicobacter pylori treatment. The study aims to compare the effectiveness and safety of 14-day amoxicillin-/metronidazole-based quadruple regiment and classical quadruple regiment for Helicobacter pylori eradication.

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Detailed Description

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Helicobacter pylori is the most successful human pathogen infecting an estimated 50% of the global population. It is a common and potentially curable cause of dyspepsia and peptic ulcer disease. Eradication in patients with peptic ulcer or even functional or non-investigated dyspepsia is a cost effective approach.

Most Consensus Conferences and Clinical Guidelines recommend the prescription of a triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole, as first-line treatment. However, the effectiveness of these triple-therapy regimens seems to have diminished over time, largely as a result of emerging resistance of the organism to clarithromycin. Due to the low efficacy achieved with these treatments, they have been deemed as unethical comparators in clinical trials. As antimicrobial resistance becomes more prevalent worldwide, treatment failure rates are likely to continue increasing, suggesting that new regimens for H pylori eradication must be sought.

Bismuth-containing quadruple therapies have been used widely in H. pylori therapy with many permutations of doses and durations and with variable results. Classical bismuth-based quadruple therapy containing a PPI, bismuth, tetracycline and metronidazole has been recommended as the first-line treatment by the Maastricht IV Consensus Conference report and H. pylori Study Group of Chinese Society of Gastroenterology. But this regiment has high rate of side effects because of tetracycline. Standard triple therapy-based, bismuth-containing quadruple Therapy is also an alternative. Though addition bismuth and prolonging treatment duration can overcome H. pylori resistance to clarithromycin, its use as a first-line treatment is limited in areas of high clarithromycin resistance.

Amoxicillin has low resistance rate as well as low percentage of side effects. The combination of amoxicillin and metronidazole in bismuth-containing quadruple therapy may be a better choice, which can avoid clarithromycin resistance and reduce side effects. Therefore, we will do a randomized trial to compare the eradication rate of 14-day amoxicillin and metronidazole based bismuth-containing quadruple therapy with amoxicillin and clarithromycin based quadruple therapy for Helicobacter pylori infection.

Conditions

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Dyspepsia Peptic Ulcer

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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Amoxicillin/metronidazole

Amoxicillin/metronidazole-based quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, Metronidazole 400mg qid

Group Type EXPERIMENTAL

Lansoprazole

Intervention Type DRUG

antisecretory drug of each quadruple therapy

Bismuth Potassium Citrate

Intervention Type DRUG

one component of each quadruple therapy

Amoxicillin

Intervention Type DRUG

antibiotic of each quadruple therapy

Metronidazole

Intervention Type DRUG

antibiotic of the amoxicillin/metronidazole-based quadruple therapy

Amoxicillin/clarithromycin

Amoxicillin/clarithromycin-based quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid

Group Type ACTIVE_COMPARATOR

Lansoprazole

Intervention Type DRUG

antisecretory drug of each quadruple therapy

Bismuth Potassium Citrate

Intervention Type DRUG

one component of each quadruple therapy

Amoxicillin

Intervention Type DRUG

antibiotic of each quadruple therapy

Clarithromycin

Intervention Type DRUG

antibiotic of the amoxicillin/clarithromycin-based quadruple therapy

Interventions

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Lansoprazole

antisecretory drug of each quadruple therapy

Intervention Type DRUG

Bismuth Potassium Citrate

one component of each quadruple therapy

Intervention Type DRUG

Amoxicillin

antibiotic of each quadruple therapy

Intervention Type DRUG

Metronidazole

antibiotic of the amoxicillin/metronidazole-based quadruple therapy

Intervention Type DRUG

Clarithromycin

antibiotic of the amoxicillin/clarithromycin-based quadruple therapy

Intervention Type DRUG

Other Intervention Names

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proton pump inhibitor Bismuth antibiotic antibiotic antibiotic

Eligibility Criteria

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Inclusion Criteria

* Participants with non-investigated/functional dyspepsia or scarred peptic ulcer with indication of H pylori eradication treatment
* Ability and willingness to participate in the study and to sign and give informed consent
* confirmed H pylori infection by at least one of the following methods: C13-urea breath test, histology, rapid urease test or bacterial culture.

Exclusion Criteria

* patients with peptic ulcer
* previous H. pylori eradication therapy
* Age below 18 years
* major systemic diseases
* previous gastric surgery
* pregnancy or breastfeeding
* allergy to any of the study drugs
* receipt of anti-secretory therapy, antibiotics or bismuth salts 4 weeks prior to inclusion

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No