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Completed

NCT Number: NCT05301725

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

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.

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Key information

Conditions

Helicobacter Pylori; Eradication Rate

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu hosipital

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PPI regimen

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 regimen

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.

Primary outcomes

  1. Rate of eradication success

    Time frame: 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.

  2. Prevalence of adverse events

    Time frame: 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

  3. Number of participants with good compliance

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2022
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.