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

Completed

• Conditions: Helicobacter Pylori; Eradication Rate
• Interventions: Other: P-CAB regimen; Other: PPI regimen

• Registration Number: NCT05301725
• Lead Sponsor: Shandong University

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2022-02-14
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-28
• Last Update Submitted: 2022-03-28
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 670

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
P-CAB group	P-CAB regimen	P-CAB regimen
PPI group	PPI regimen	PPI regimen

Primary Outcome Measures

Name	Time	Method
Rate of eradication success	1 month	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.
Prevalence of adverse events	1 month	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
Number of participants with good compliance	1 month	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

Trial Locations

Locations (1)

Qilu hosipital; 🇨🇳 Jinan, Shandong, China