Eradication Efficacy and Safety of Two Rescue Treatments for Helicobacter Pylori Infection

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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The aim of this study was to evaluate the efficacy and safety of high-dose dual therapy compared with furazolidone-based quadruple therapy as a rescue treatment for helicobacter pylori infection.

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Detailed Description

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Helicobacter pylori (H. pylori) infection is common worldwide and is strongly associated with peptic ulcer and gastric cancer. The eradication rate of H. pylori treatment is limited in the recent years although standard first-line therapy is used. There is a growing antibiotic resistance due to antibiotic consumption for other infections. The failure of first-line therapy for H. pylori can significantly limit the efficacy of the subsequent rescue therapies.

H. pylori resistance to amoxicillin (AMO), both primary and acquired, have been reported to be uncommon. The bactericidal effect of AMO against H. pylori is pH- and time- dependent with a sustaining higher intragastric pH. Thus, the therapy consisting of high-dose PPI and AMO may have advantage over the currently recommended furazolidone-based quadruple therapy.

Conditions

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H. Pylori Infection

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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High-dose dual therapy group

esomeprazole 20mg qid plus amoxicillin 750mg qid were used in the high-dose dual therapy group

Group Type EXPERIMENTAL

esomeprazole plus amoxicillin

Intervention Type DRUG

amoxicillin 750mg QID + esomeprazole 20mg QID for 14 days

Furazolidone-based quadruple therapy

furazolidone 100mg bid + amoxicillin 1000mg bid + esomeprazole 20mg bid + bismuth potassium citrate 1000mg(220mg of bismuth) bid were used in the Furazolidone-based quadruple therapy

Group Type ACTIVE_COMPARATOR

amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole

Intervention Type DRUG

amoxicillin 1000mg BID + furazolidone 100mg BID + bismuth potassium citrate 600mg BID + esomeprazole 20mg BID for 14 days

Interventions

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esomeprazole plus amoxicillin

amoxicillin 750mg QID + esomeprazole 20mg QID for 14 days

Intervention Type DRUG

amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole

amoxicillin 1000mg BID + furazolidone 100mg BID + bismuth potassium citrate 600mg BID + esomeprazole 20mg BID for 14 days

Intervention Type DRUG

Other Intervention Names

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HDDT FT

Eligibility Criteria

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Inclusion Criteria

* The patients who were diagnosed with persistent H. pylori infection and had previously failed one or more courses of eradication therapies that included amoxicillin, clarithromycin, or nitroimidazole.

Exclusion Criteria

* Age \< 18 years old.
* The time frame was less than 6 months from the previous eradication therapy.
* The previous eradication therapy included furazolidone.
* Allergic to the medication.
* Pregnant or lactating women.
* Comorbidities of severe conditions like hepatic, renal or cardiorespiratory diseases or malignancy.
* Administration of antibiotics, bismuth or PPI in the preceding 4 weeks.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No