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NCT Number: NCT05250050

Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment

This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the Helicobacter pylori treatment.

Why the study stopped: Unable to complete in vitro culture of Helicobacter pylori in our hospital
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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Huashan Hospital, Fudan University, Shanghai, Shanghai Municipality, China

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About this study

This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the treatment of Helicobacter pylori in patients with chronic gastritis. This study will compare the efficacy of individualized and empirical drug sensitivity regimens, and conduct cost-effectiveness analysis to provide pharmacoeconomic guidance for clinical decision-making. At the same time, it will provide reference for the reasonable pricing of H.pylori drug sensitivity test and considering the health benefits brought by its inclusion in medical insurance.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
  • 18-75 years old on the day of signing the ICF.
  • Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.

Exclusion criteria

  • Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
  • Subjects or guardians refused to participate in the trial.
  • Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
  • Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.
  • Pregnant or lactating women.
  • Active peptic ulcer.
  • allergic to drugs used in the trial.
  • any other circumstances that are not suitable for recruitment.

Treatment and study plan

Esomeprazole

Drug

20mg bid

Bismuth Potassium Citrate

Drug

0.6g bid

Metronidazole

Drug

0.4g qid

Clarithromycin

Drug

0.5g bid

Levofloxacin

Drug

0.5g qd

Amoxicillin

Drug

1g bid

Tetracycline

Drug

0.5g qid

Primary outcomes

  1. Eradication rate of Helicobacter pylori

    Time frame: 6 weeks

    Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value).

Secondary outcomes

  1. Eradication rate of Helicobacter pylori resistant strains

    Time frame: 6 weeks

    Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method.

  2. Eradication rate of Helicobacter pylori susceptible strains

    Time frame: 6 weeks

    Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method.

Other outcomes

  1. Adherence rate

    Time frame: 2 weeks during therapy

    The proportion of subjects with good adherence. Good adherence was defined as that subjects took more than 80% of the total medication.

  2. Frequency of adverse events

    Time frame: 2 weeks during therapy

    Any possible adverse events during the 14-day treatment period were recorded.

  3. Average cost of each group

    Time frame: 6 weeks

    Average medical cost related to therapy and followup in each group

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Clinical Efficacy and Health Economic Evaluation of Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment:Multicenter Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 22, 2022
Registry last updated
Aug 4, 2026

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.

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