Bismuth Quadruple Therapy in Helicobacter Pylori Rescue Therapy of Different Tetracycline Doses and Frequencies.

March 25, 2023 updated by: Yanqing Li, Shandong University

Bismuth Quadruple Therapy in Helicobacter Pylori Rescue Therapy: A Multicenter Randomized Non-Inferiority Trial of Different Tetracycline Doses and Frequencies.

The researchers collect H.pylori-positive patients who need rescue therapy 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 and patient compliance of each group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The researchers collect H.pylori-positive patients who need rescue therapy 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 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 and patient compliance of each group were calculated.

According to the dose and frequency of tetracycline, 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 40mg bid

Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 40mg bid

Study Type

Interventional

Enrollment (Anticipated)

260

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 Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Department of Gastroenterology,QiLu Hospital,Shandong University

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients aged 18-70.
  2. Patients with H.pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).
  3. Patients who have previous failed H. pylori eradication treatment, and ≤ 2 times.

Exclusion Criteria:

  1. 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%.
  2. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
  3. Patients with active gastrointestinal bleeding.
  4. Patients with a history of upper gastrointestinal surgery.
  5. Patients allergic to treatment drugs.
  6. Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
  7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
  8. 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
Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 40mg bid
Drug: Tetracycline 500mg tid
Amoxicillin 1000mg bid +Tetracycline 500mg tid +Bismuth+Esomeprazole 40mg bid
Other Names:
  • Amoxicillin
  • Bismuth
  • Esomeprazole
Active Comparator: Qid group
Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 40mg bid
Drug: Tetracycline 500mg qid
Amoxicillin 1000mg bid +Tetracycline 500mg qid +Bismuth+Esomeprazole 40mg bid
Other Names:
  • Amoxicillin
  • Bismuth
  • Esomeprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eradication rate
Time Frame: through study completion, an average of 1.5 years
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.
through study completion, an average of 1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of adverse reactions
Time Frame: through study completion, an average of 1.5 years
Rate of adverse reactions
through study completion, an average of 1.5 years
Patient compliance
Time Frame: through study completion, an average of 1.5 years
Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.
through study completion, an average of 1.5 years

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
Taierzhuang District People's Hospital
People's Hospital of Zhengzhou University
Yuncheng County Hospital of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Yanqing Li, Ph.D, 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)

March 12, 2023

Primary Completion (Anticipated)

June 15, 2024

Study Completion (Anticipated)

June 15, 2024

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 25, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

March 25, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023000

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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