Rescue Therapy for Helicobacter Pylori Infection

October 23, 2023 updated by: Hong Lu, MD, Shanghai Jiao Tong University School of Medicine

Rifabutin-containing Triple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial

Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

357

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
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Principal Investigator:
          • Hong Lu, M.D.,Ph.D
        • Sub-Investigator:
          • Xiao Liang, M.D.,Ph.D
        • Contact:
        • Sub-Investigator:
          • Jinnan Chen, M.M.
        • Sub-Investigator:
          • Yixian Guo, M.M.
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Songjiang District Central Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:

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
Active Comparator: Tetracycline Bismuth Quadruple Therapy
Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid
Drug: Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
Drug: Tetracycline
Antibiotics for H. pylori eradication
Drug: Metronidazole
Antibiotics for H. pylori eradication
Drug: Vonoprazan
Proton pump inhibitor
Experimental: Rifabutin Triple Therapy
Vonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid
Drug: Amoxicillin
Antibiotics for H. pylori eradication
Drug: Vonoprazan
Proton pump inhibitor
Drug: Rifabutin
Antibiotics for H. pylori eradication
Experimental: Dual Therapy
Vonoprazan 20mg bid, amoxicillin 1000mg tid
Drug: Amoxicillin
Antibiotics for H. pylori eradication
Drug: Vonoprazan
Proton pump inhibitor

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)

May 16, 2023

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rjhy20230001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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