Optimization of Minocycline for Helicobacter Pylori Rescue Treatment

March 21, 2026 updated by: Hong Lu, MD, Shanghai Jiao Tong University School of Medicine

Optimization of Minocycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Multicentre, Randomized Controlled Trial

The efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events (55.4%). Optimization of minocycline-based regimen to achieve high eradication rate with fewer adverse events is imperative. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy with different dosage of minocycline and metronidazole compared to classical bismuth quadruple therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

480

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
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
      • Shanghai, Shanghai Municipality, China
        • Songjiang Hospital, School of Medicine, Shanghai Jiao Tong University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The Second Affiliated Hospital of Zhejiang University School of Medicine

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 and with previous treatment experience

Exclusion Criteria:

  • subjects naive to H. pylori treatment,
  • under 18 or over 80 years old
  • history of gastrectomy
  • pregnant or lactating women
  • Previous history of tuberculosis
  • Allergy to any of the study drugs
  • severe systemic diseases or malignancy
  • 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Minocycline group A
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg tid, Metronidazole 400mg tid
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
Experimental: Minocycline group B
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg qid
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
Experimental: Minocycline group C
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg tid
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
Active Comparator: Tetracycline group
Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
Drug: Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
Drug: Tetracycline,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
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
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). In addition, blood test were messured to access function of liver and kidney.
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 (Actual)

February 21, 2026

Study Completion (Actual)

February 21, 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, 2026

Last Update Submitted That Met QC Criteria

March 21, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rjhy20240816

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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