Efficacy And Safety of Bismuth-Tetracycline-Rabeprazole Triple For First-Line Eradication of Helicobacter Pylori Infection

August 22, 2026 updated by: Chih-An Shih, MD

Efficacy And Safety of Bismuth-Tetracycline-Rabeprazole Triple Versus Bismuth Quadruple Therapies For First-Line Eradication of Helicobacter Pylori Infection: A Single-Center, Randomized Controlled Trial

Most international treatment guidelines currently recommend a 14-day bismuth quadruple therapy as the first-line treatment for Helicobacter pylori infection, especially in areas with high clarithromycin resistance. While this therapy boasts good eradication rates, its administration is complex and has a high incidence of adverse reactions. However, tetracycline is one of the most effective anti-Helicobacter pylori antibiotics, with a resistance rate of less than 3%. This study prospectively evaluates the efficacy and safety of a 14-day triple therapy (high-dose tetracycline combined with bismuth and PPI) versus a 14-day bismuth quadruple therapy as first-line eradication therapy. This novel single-antibiotic therapy has the potential to become a new standard of care for Helicobacter pylori eradication.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

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

  • Name: Chih-An Shih, Doctor of Medicine
  • Phone Number: 886-8-8329966
  • Email: dreric921@gmail.com

Study Contact Backup

Study Locations

  • Taiwan
      • Pingtung City, Taiwan, 928004
        • Antai Medical Care Corporation, Antai Tian-Sheng Memorial Hospital

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:

adult patients (aged ≥18 years) who underwent esophagogastroduodenoscopy for the evaluation of gastrointestinal symptoms at Antai Tian-Sheng Memorial Hospital. Eligible individuals were invited to participate in an H. pylori screening program. Those who met either of the following criteria were considered for enrollment: (1) positive results from both the rapid urease test and histology, or (2) a positive culture result.

Exclusion Criteria:

(1) previous H. pylori eradication therapy, (2) a history of gastrectomy, (3) allergy to any of the eradication medications used in this study, (4) antibiotic use within 4 weeks before treatment, (5) the absence of post-treatment assessment for H. pylori eradication.

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: Bismuth-Tetracycline-Rabeprazole Triple Therapy
Bismuth、Tetracycline、Rabeprazole
Drug: Bismuth
14-day Bismuth-Tetracycline-Rabeprazole Triple
Other Names:
  • Rabeprazole
  • Tetracycline
Drug: Bismuth quadruple therapy
Bismuth quadruple therapy, combining Rabeprazole, Tetracycline, Bismuth, and Metronidazole
Other Names:
  • Rabeprazole
  • Metronidazole
  • Tetracycline
Active Comparator: Bismuth Quadruple Therapy
Bismuth、Tetracycline、Rabeprazol、Metronidazole
Drug: Bismuth
14-day Bismuth-Tetracycline-Rabeprazole Triple
Other Names:
  • Rabeprazole
  • Tetracycline
Drug: Bismuth quadruple therapy
Bismuth quadruple therapy, combining Rabeprazole, Tetracycline, Bismuth, and Metronidazole
Other Names:
  • Rabeprazole
  • Metronidazole
  • Tetracycline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eradication rate
Time Frame: 6 weeks
Follow-up at week 2 will assess treatment adherence and adverse events. H. pylori status will be evaluated at week 6 using the C13-urea breath test. Eradication and adverse event rates will be compared between groups using the chi-square test.
6 weeks

Collaborators and Investigators

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

Sponsor

Chih-An Shih, MD

Investigators

  • Principal Investigator: Chih-An Shih, Doctor of Medicine, Antai Medical Care Corporation, Antai Tian-Sheng Memorial Hospital

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 (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

August 22, 2026

First Submitted That Met QC Criteria

August 22, 2026

First Posted (Actual)

August 26, 2026

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 22, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AntaiMedCare

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

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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