Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment of Different Tetracycline Doses

March 26, 2024 updated by: Xiuli Zuo, Shandong University

Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment: A Multicenter Randomized Clinical Trial of Different Tetracycline Doses and Frequencies.

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of bismuth quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a dose and frequency of tetracycline 500mg tid or qid of bismuth-containing quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results.

After all subjects were tested, the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group were calculated.

According to the course of treatment, it is randomized into a tid treatment group and a qid treatment group. The two groups of bismuth quadruple regimens are the same, as follows:

Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 20mg bid Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 20mg bid

Study Type

Interventional

Enrollment (Actual)

406

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
      • Zhengzhou, Henan, China
        • Zhengzhou Central Hospital
        • Contact:
          • Lidong Xu
    • Shandong
      • Jinan, Shandong, China, 257000
        • Qilu hosipital
      • Taierzhuang, Shandong, China
        • Taierzhuang District People's Hospital
        • Contact:
          • Ruili Li
      • Yuncheng, Shandong, China
        • Yuncheng Hospital of Traditional Chinese Medicine
        • Contact:
          • Qiumei Zhang
      • Zibo, Shandong, China
        • PKUCare Luzhong Hospital
      • Zibo, Shandong, China
        • Zibo central Hospital
        • Contact:
          • Qing Zhao

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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18-70.
  • Patients with H.pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).
  • Patients who have never received H. pylori eradication treatment.

Exclusion Criteria:

  • Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
  • Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
  • Patients with active gastrointestinal bleeding.
  • Patients with a history of upper gastrointestinal surgery.
  • Patients allergic to treatment drugs.
  • Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
  • Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
  • Patients who are unwilling or incapable to provide informed consents.

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: Tid group
Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 20mg bid
Drug: Amoxicillin
Included in quadruple eradication medication.
Drug: Tetracycline tid
Included in quadruple eradication medication.
Drug: Bismuth Potassium Citrate
Included in quadruple eradication medication.
Drug: Colloidal Bismuth Pectin
Included in quadruple eradication medication.
Drug: Esomeprazole 20mg
Included in quadruple eradication medication.
Active Comparator: Qid group
Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 20mg bid
Drug: Amoxicillin
Included in quadruple eradication medication.
Drug: Bismuth Potassium Citrate
Included in quadruple eradication medication.
Drug: Colloidal Bismuth Pectin
Included in quadruple eradication medication.
Drug: Esomeprazole 20mg
Included in quadruple eradication medication.
Drug: Tetracycline qid
Included in quadruple eradication medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eradication rate
Time Frame: Immediately after follow-up check.
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Immediately after follow-up check.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of adverse reactions
Time Frame: Immediately after follow-up check.
Rate of adverse reactions
Immediately after follow-up check.
Patient compliance
Time Frame: Immediately after follow-up check.
Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.
Immediately after follow-up check.
Cost-effectiveness index
Time Frame: Immediately after follow-up check.
Ratio of costs to effectiveness
Immediately after follow-up check.

Collaborators and Investigators

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

Sponsor

Shandong University

Collaborators

Zibo Central Hospital
Peking University Care Luzhong Hospital
Yuncheng Traditional Chinese Medicine Hospital
Taierzhuang District People's Hospital
Zhengzhou Central Hospital

Investigators

  • Principal Investigator: Xiuli Zuo, MD,PhD, Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2022

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

June 18, 2022

First Submitted That Met QC Criteria

June 18, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-SDU-QILU-G004

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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