High-dose Dual Therapy with Different Administration Frequencies

Shanghai Jiao Tong University School of Medicine327 enrolled

Overview

This study is a single center, randomized controlled clinical study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 327 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.

According to relevant literature research, amoxicillin TID groups (including before meal group and after meal group) were given Vonorasen (Takeda China) 20mg bid and Amoxicillin 1.0 TID (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.). Amoxicillin Qid group was given Vonorasen (Takeda China) 20mg bid and Amoxicillin 0.75 Qid (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.), all the drugs were purchased by the patients from the hospital. The three groups were treated for 14 days respectively, and 13C urea breath test was performed 6 weeks after drug withdrawal. The negative ones were judged as HP eradication.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

327

Conditions

Helicobacter Pylori Infection

Interventions

vonoprazanDRUG

Potassium competitive acid blocker

AmoxicillinDRUG

Antibiotics for H. pylori eradication

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ability and willingness to participate in the study and to sign and give informed consent * Confirmed H. pylori infection Exclusion Criteria: * Pregnant and lactating women; * History of gastrointestinal malignancies; * History of previous subtotal gastrectomy; * Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc; * History of hematological diseases * People who are allergic to drugs; * The guardian or patient refused to join the group; * Alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors; * No legal capacity or poor self-knowledge * administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Helicobacter pylori eradication rate

Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-rea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).

Time frame: Six weeks after completion of therapy

Secondary Outcomes

Rate of adverse events

The subjects were asked to record side effects and discomfort during treatment and actual drug administration.

Time frame: Within 7 days after completion of therapy

Compliance rate

Compliance was defined as poor when they had taken less than 80% of the total medication

Time frame: Within 7 days after completion of therapy

Data from ClinicalTrials.gov

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