Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori（SHARE2302)

January 9, 2024 updated by: Yanqing Li, Shandong University

Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori : A Multicenter Randomized Non-Inferiority Trial

Helicobacter pylori (H. pylori) infection is a common global infectious disease of the gastrointestinal tract. Helicobacter pylori eradication can effectively prevent the development of gastric cancer.The researchers collect H.pylori-positive patients who need native therapy. The subjects were randomized to receive7 days and 14 days 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

Related studies have shown that 7-day bismuth quadruple therapy is not inferior to 14-day bismuth quadruple therapy in the eradication of clarithromycin-resistant H. pylori.The results of the current study conducted by our team on the eradication of H. pylori in 10-day versus 14-day courses of bismuth quadruple therapy showed that the 10-days (92.09%) was not inferior to the 14-days(92.38%), but the incidence of adverse effects was significantly lower in the 10-day courses than in the 14-days(30.62%). If it can be demonstrated that the eradication rate of the 7-day course of bismuth quadruplex is close to that of the 14-days, then the 7-day course may be chosen.

The researchers collect H.pylori-positive patients who need native therapy. 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 7days or 14days 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 therapy, it is randomized into a 7days treatment group and a 14 days treatment group. The two groups of bismuth quadruple regimens are the same, as follows:

7days group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid 14days group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid

Study Type

Interventional

Enrollment (Estimated)

254

Phase

  • Not Applicable

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
        • 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:

  1. Patients aged 18-70.
  2. Without active hepatitis.
  3. Helicobacter pylori infection (either positive for rapid urease test, C13/C14 urea breath test).
  4. Patients who have not previously received helicobacter pylori eradication therapy.

Exclusion Criteria:

  1. Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 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: 7 days
Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid
Procedure: 7days bismuth quadruple
Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid*7days
Other Names:
  • Amoxicillin
  • Bismuth
  • Tetracycline
  • Tegoprazan
Active Comparator: 14 days
Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid
Procedure: 14 days bismuth quadruple
Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid*14days
Other Names:
  • Amoxicillin
  • Bismuth
  • Tetracycline
  • Tegoprazan

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 90%-100% of the dosage that should be taken.
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

The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine
Zaozhuang Municipal Hospital
Zibo Maternal and Child Health Hospital
Binzhou Maternal and Child Health Hospital
Jinxiang County People's Hospital
Linyi Yizhou Hospital
Yantai Penglai Traditional Chinese Medicine Hospital

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)

September 2, 2023

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

August 11, 2023

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHARE2302

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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