Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori Infection

Shandong University60 enrolled

Overview

The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.

Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted. Few published paper evaluated the efficacy of 14-day furazolidone containing concomitant therapy in the third line treatment. This study aims to propose a new concomitant therapy for the patients with two or more treatment failure, and then evaluates whether adverse effects are tolerable. .

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Helicobacter Pylori Infection

Interventions

Amoxicillin,Tetracycline,Furazolidone,Levofloxacin,Vonoprazan fumarate, Esomeprazole ,DRUG

Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 18-70 with persistent H. pylori infection. * Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report. Exclusion Criteria: * Patients unable or unwilling to receive gastroscopy. * Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks. * Patients with gastorectomy, acute GI bleeding and advanced gastric cancer. * History of allergy to any of the drugs used in the study. * Severe concomitant cardiovascular, respiratory, or endocrine diseases,clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk. * Currently pregnant or lactating. * Severe neurologic or psychiatric disorders. * Alcohol abuse or drug addiction. * Patients with compliance lower than 90% in any previous treatment are not included. * Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Locations (1)

Qilu hospital

Jinan, Shandong, China

Outcomes

Primary Outcomes

Eradication rates

Six weeks after completion of treatment,number of patients get H.pylori eradicated will be investigated.Then eradication rate will be calculated by using intention-to-treat analysis and per-protocol analysis. results will be investigated by an independent researcher.Then eradication rate in each group will be calculated by using intention-to-treat analysis and per-protocol analysis. of Helicobacter pylori infection. The ITT analysis includes all the patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow up.

Time frame: 6 month

Secondary Outcomes

The rate of adverse events happening

At the follow-up,adverse events complained by patients will be recorded by an independent researcher#meanwhile a 8 point visual analog scale (VAS) was used to evaluate severity of adverse events.

Time frame: 6 month

Compliance of patients

compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good when more than 80% or less than 120% of the total pills were taken.

Time frame: 6 month

Data from ClinicalTrials.gov

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