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

Eradication Efficacy and Safety of High-dose Dual Therapy Compared With Furazolidone-based Quadruple Therapy as a Rescue Treatment for Helicobacter Pylori Infection: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: H. Pylori Infection
• Intervention / Treatment: Drug: esomeprazole plus amoxicillin; Drug: amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole

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 Type: Interventional
• Enrollment (Anticipated): 186
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie CHEN, MD; Phone Number: 8613764633539; Email: chen.jie5@zs-hospital.sh.cn
• Study Contact Backup: Name: Chengzhao Weng, MD; Phone Number: 8615859253190; Email: weng.chengzhao@zsxmhospital.com

Study Locations

• China
  • Xiamen, China, 86361015
    • Recruiting
    • Zhongshan Hospital Xiamen Branch
    • Contact: Jie CHEN, MD; Phone Number: 8613764633539; Email: chen.jie5@zs@hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-dose dual therapy group; esomeprazole 20mg qid plus amoxicillin 750mg qid were used in the high-dose dual therapy group	Drug: esomeprazole plus amoxicillin; amoxicillin 750mg QID + esomeprazole 20mg QID for 14 days; Other Names: HDDT
Active Comparator: 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	Drug: amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole; amoxicillin 1000mg BID + furazolidone 100mg BID + bismuth potassium citrate 600mg BID + esomeprazole 20mg BID for 14 days; Other Names: FT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eradication rate	eradication rate of H pylori, presenting with negative results on the 13C-UBT test	42 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Wei Jiang, MD, Xiamen branch of Zhongshan Hospital, Fudan University

Publications and helpful links

General Publications

• Yang J, Zhang Y, Fan L, Zhu YJ, Wang TY, Wang XW, Chen DF, Lan CH. Eradication Efficacy of Modified Dual Therapy Compared with Bismuth-Containing Quadruple Therapy as a First-Line Treatment of Helicobacter pylori. Am J Gastroenterol. 2019 Mar;114(3):437-445. doi: 10.14309/ajg.0000000000000132. Erratum In: Am J Gastroenterol. 2019 May;114(5):835.
• Yu L, Luo L, Long X, Liang X, Ji Y, Graham DY, Lu H. High-dose PPI-amoxicillin dual therapy with or without bismuth for first-line Helicobacter pylori therapy: A randomized trial. Helicobacter. 2019 Aug;24(4):e12596. doi: 10.1111/hel.12596. Epub 2019 May 20.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Natriuretic Agents; Anti-Bacterial Agents; Diuretics; Respiratory System Agents; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Monoamine Oxidase Inhibitors; Expectorants; Antacids; Anti-Infective Agents, Urinary; Renal Agents; Antitrichomonal Agents; Amoxicillin; Esomeprazole; Bismuth; Potassium Citrate; Furazolidone
• Other Study ID Numbers: JW-Hp2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be available to other researchers. We may balance the potential benefits and risks for each request and then provide the data that could be shared.
• IPD Sharing Time Frame: The data will be available once the results have been uploaded in the PRS system and will be available for 2 years.
• IPD Sharing Access Criteria: Emails could be sent to the emails below to obtain the shared data: chen.jie5@zs-hospital.sh.cn, weng.chengzhao@zsxmhospital.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No