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

Not Applicable

• Conditions: H. Pylori Infection
• Interventions: Drug: amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole; Drug: esomeprazole plus amoxicillin

• Registration Number: NCT05176821
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-04
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-05
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 186

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Furazolidone-based quadruple therapy	amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole	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
High-dose dual therapy group	esomeprazole plus amoxicillin	esomeprazole 20mg qid plus amoxicillin 750mg qid were used in the high-dose dual therapy group

Primary Outcome Measures

Name	Time	Method
eradication rate	42 days	eradication rate of H pylori, presenting with negative results on the 13C-UBT test

Secondary Outcome Measures

Name	Time	Method
frequency of the adverse events	42 days	incidence rate of the adverse events, including dyspepsia, nausea, vomiting, abdominal pain, bloating, diarrhea, dizziness, headache, skin rash, fatigue and fever.
compliance rate of the drugs	42 days	Compliance was defined as good when they had taken more than 80% of the total medication.

Trial Locations

Locations (1)

Zhongshan Hospital Xiamen Branch; 🇨🇳 Xiamen, China