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

Fudan University

Status: Enrolling

Conditions: H. Pylori Infection

Treatments: Drug: amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole; Drug: esomeprazole plus amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT05176821

JW-Hp2021

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 186 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

High-dose dual therapy group

Experimental group

Description:

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

Treatment:

Drug: esomeprazole plus amoxicillin

Furazolidone-based quadruple therapy

Active Comparator group

Description:

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

Treatment:

Drug: amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole