Efficacy of Different Acid Suppressors in Bismuth-containing Quadruple Therapy Against Helicobacter Pylori

Study Overview
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Brief Summary
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Ａretrospective study was conducted to compare the efficacy, safety, and cost-effectiveness of traditional proton pump inhibitors (PPI ) and Potassium-competitive acid blockers ( P-CAB )for clarithromycin-based bismuth-containing quadruple therapy in the management of Helicobacter pylori eradication.

Detailed Description
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This study retrospectively enrolled participants with H. pylori infection who received bismuth quadruple regimen containing clarithromycin. The basic information, treatment results, adverse reactions and compliance of the patients were collected. According to the type of acid inhibitors, participants were divided into traditional PPI group and P-CAB group. Traditional PPI group which were divided into lansoprazole group and esomeprazole group. The eradication rate, safety, compliance of H. pylori in different treatment regimens was evaluated. Multivariate analysis was performed to identify predictors of eradication failure.

Official Title
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Efficacy of Different Acid Suppressors in Bismuth-containing Quadruple Therapy as First-line Treatment Against Helicobacter Pylori

Conditions
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Helicobacter Pylori; Eradication Rate

Intervention / Treatment
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* Other: PPI regimen
* Other: P-CAB regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants aged 18-75 years with persistent H. pylori infection. Participants received clarithromycin-based bismuth-containing quadruple therapy. Exclusion Criteria: Patients received rescue therapy Patients treated with PPI, P-CAB,bismuth and antibiotics in the previous 4 weeks Patients with gastorectomy Currently pregnant or lactating or other conditions unable to receive therapy 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 Severe neurologic or psychiatric disorders Information incomplete

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PPI group<br>PPI regimen | Other: PPI regimen<br>* All patients received PPI regimen( lansoprazole or esomeprazole,bismuth amoxicillin,clarithromycin for14 days). Demographic data,treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved.<br>|
| P-CAB group<br>P-CAB regimen | Other: P-CAB regimen<br>* All patients received P-CAB regimen(vonoprazan,bismuth ,amoxicillin,clarithromycin for14 days). Demographic data,treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of eradication success | Six weeks after completion of treatment, numbers of patients get H.pylori eradicated supported by negative 13C-UBT results will be investigated by an independent researcher. Then eradication rate in each group will be calculated by using intention-to-treat (ITT) analysis, modified intention to treat analysis (MITT) and per-protocol (PP) analysis. The ITT analysis includes all the patients who take at least one dose of the study medications. The MITT analysis is limited to patients who complete follow-up.The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up. | 1 month | 
| Prevalence of adverse events | At the follow-up, adverse events complained by patients will be recorded by an independent researcher, meanwhile CTCAE v5.0 was used to evaluate severity of adverse events.The prevalence of adverse events was compared between the two group | 1 month | 
| Number of participants with good compliance | Compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good whenmore than 90% or less than 120% of the total pills were taken | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori,eradication therapy