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Not yet recruitingNCT07788053Updated Aug 26, 2026

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

An interventional study of Bismuth and Bismuth quadruple therapy in Helicobatcer Pylori and First-Line Eradication, sponsored by Chih-An Shih, MD. Not yet recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Chih-An Shih, MD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Helicobatcer Pylori
  • First-Line Eradication

Keywords

  • bismuth
  • triple therapy
  • tetracycline
  • proton pump inhibitor
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    Bismuth-Tetracycline-Rabeprazole Triple Therapy

    Bismuth、Tetracycline、Rabeprazole

    Drug: Bismuth · Drug: Bismuth quadruple therapy

  • Active comparator
    Bismuth Quadruple Therapy

    Bismuth、Tetracycline、Rabeprazol、Metronidazole

    Drug: Bismuth · Drug: Bismuth quadruple therapy

Interventions

  • DrugBismuth

    14-day Bismuth-Tetracycline-Rabeprazole Triple

    Also known as: Tetracycline, Rabeprazole

  • DrugBismuth quadruple therapy

    Bismuth quadruple therapy, combining Rabeprazole, Tetracycline, Bismuth, and Metronidazole

    Also known as: Rabeprazole, Tetracycline, Metronidazole

05

What researchers measure

Primary outcomes

  1. eradication rate

    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.

    Time frame: 6 weeks

06

Study locations

1 site
  • Antai Medical Care Corporation, Antai Tian-Sheng Memorial Hospital
    Pingtung City, 928004, Taiwan
07

References and documents

Publications

  • Gao W, Liu J, Wang X, Li J, Zhang X, Ye H, Li J, Dong X, Liu B, Wang C, Xu Y, Teng G, Tian Y, Dong J, Ge C, Cheng H. Simplified Helicobacter pylori therapy for patients with penicillin allergy: a randomised controlled trial of vonoprazan-tetracycline dual therapy. Gut. 2024 Aug 8;73(9):1414-1420. doi: 10.1136/gutjnl-2024-332640. PubMed 38906695 ↗
  • Gao W, Xu Y, Liu J, Wang X, Dong X, Teng G, Liu B, Dong J, Ge C, Ye H, Zhang X, Cheng H. A real-world exploratory study on the feasibility of vonoprazan and tetracycline dual therapy for the treatment of Helicobacter pylori infection in special populations with penicillin allergy or failed in previous amoxicillin-containing therapies. Helicobacter. 2023 Apr;28(2):e12947. doi: 10.1111/hel.12947. Epub 2023 Jan 17. PubMed 36650673 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07788053
Lead sponsor
Chih-An Shih, MD
Responsible party
Chih-An Shih, MD (Antai Medical Care Corporation, Antai Tian-Sheng Memorial Hospital, Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Ta) — Sponsor-investigator
First posted
Aug 26, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2029 (estimated)
Completion
Sep 1, 2029 (estimated)
Last update
Aug 26, 2026

Study contacts

Chih-An Shih, Doctor of Medicine
Contact
dreric921@gmail.com
886-8-8329966
Chang-Yi Li, Bachelor
Contact
victorlee0702@hotmail.com
886-8-8329966
Chih-An Shih, Doctor of Medicine
principal investigator · Antai Medical Care Corporation, Antai Tian-Sheng Memorial Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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