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

December 26, 2024 updated by: Hong Lu, MD, Shanghai Jiao Tong University School of Medicine
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Hebi, Henan, China
        • Recruiting
        • Hebi People's Hospital
        • Contact:
      • Jiaozuo, Henan, China
        • Recruiting
        • Jiaozuo People's Hospital
        • Contact:
      • Luoyang, Henan, China
        • Recruiting
        • Luoyang Central Hospital
        • Contact:
      • Pingdingshan, Henan, China
        • Recruiting
        • The First People'S Hospital of Ping Ding Shan
        • Contact:
      • Xuchang, Henan, China
        • Recruiting
        • Xuchang Central Hospital
        • Contact:
      • Zhengzhou, Henan, China
        • Recruiting
        • The Third People's Hospital of Zhengzhou
        • Contact:
      • Zhengzhou, Henan, China
        • Recruiting
        • Zhengzhou People's Hospital
        • Contact:
      • Zhengzhou, Henan, China
        • Recruiting
        • The Second Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Zhoukou, Henan, China
        • Recruiting
        • Zhoukou Central Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:
        • Contact:
          • Hong Lu, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dual therapy
Drug: Amoxicillin
Antibiotics for H. pylori eradication
Drug: Vonoprazan
Potassium competitive acid blocker
Experimental: Minocycline bismush quadruple therapy
Drug: Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
Drug: Minocycline,Metronidazole
Antibiotics for H. pylori eradication
Drug: Vonoprazan
Potassium competitive acid blocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Six weeks after completion of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Within 7 days after completion of therapy
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
Within 7 days after completion of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rjhy20240814

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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