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

NCT ID: NCT05301725

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

670 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-12-31

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.

Conditions

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Helicobacter Pylori; Eradication Rate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PPI group

PPI regimen

PPI regimen

Intervention Type OTHER

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.

P-CAB group

P-CAB regimen

P-CAB regimen

Intervention Type OTHER

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.

Interventions

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PPI regimen

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.

Intervention Type OTHER

P-CAB regimen

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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Xiuli Zuo

Director of Qilu Hospital gastroenterology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qilu hosipital

Jinan, Shandong, China

Site Status

Countries

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China

References

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Wang J, Li YY, Lin MJ, Liu J, Lin BS, Ding YM, Wan M, Zhang WL, Kong QZ, Wang ST, Mu YJ, Duan M, Han ZX, Zuo XL, Li YQ. Vonoprazan is noninferior to proton pump inhibitors in bismuth-containing quadruple therapy for the treatment of Helicobacter pylori infection: A propensity score matching analysis. J Dig Dis. 2023 Jan;24(1):19-27. doi: 10.1111/1751-2980.13166. Epub 2023 Apr 22.

Reference Type DERIVED
PMID: 36960538 (View on PubMed)

Other Identifiers

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2022-SDU-QILU-G001

Identifier Type: -

Identifier Source: org_study_id

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