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NCT Number: NCT06561698

High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection

This study is a multicentra, prospective study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 200 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.

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Key information

Conditions

Helicobacter Pylori Infection cyclopia sequence

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hebi People's Hospital, Hebi, Henan, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ability and willingness to participate in the study and to sign and give informed consent
  • Confirmed H. pylori infection

Exclusion criteria

  • Pregnant and lactating women;
  • History of gastrointestinal malignancies;
  • History of previous subtotal gastrectomy;
  • Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc;
  • History of hematological diseases
  • People who are allergic to drugs;
  • The guardian or patient refused to join the group;
  • Alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors;
  • No legal capacity or poor self-knowledge
  • administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Treatment and study plan

Vonoprazan

Drug

Potassium competitive acid blocker

Amoxicillin

Drug

Antibiotics for H. pylori eradication

Bismuth Potassium Citrate

Drug

Gastric mucosal protective drug with anti-H. pylori effect

Minocycline,Metronidazole

Drug

Antibiotics for H. pylori eradication

Primary outcomes

  1. Helicobacter pylori eradication rate

    Time frame: Six weeks after completion of therapy

    Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).

Secondary outcomes

  1. Rate of adverse effects

    Time frame: Within 7 days after completion of therapy

    The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities)

  2. Compliance rate

    Time frame: Within 7 days after completion of therapy

    Compliance was defined as poor when they had taken less than 80% of the total medication

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2024
Registry last updated
Dec 30, 2024

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

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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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