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

NCT07788053 | Not Yet Recruiting

• 1 other identifier: AntaiMedCare
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobatcer Pylori; First-Line Eradication

Keywords

bismuth; triple therapy; tetracycline; proton pump inhibitor

Outcome Measures

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.

  6 weeks

Study Arms (2)

Bismuth-Tetracycline-Rabeprazole Triple Therapy

ACTIVE COMPARATOR

Bismuth、Tetracycline、Rabeprazole

Drug: Bismuth; Drug: Bismuth quadruple therapy

Bismuth Quadruple Therapy

ACTIVE COMPARATOR

Bismuth、Tetracycline、Rabeprazol、Metronidazole

Drug: Bismuth; Drug: Bismuth quadruple therapy

Interventions

Bismuth DRUG

14-day Bismuth-Tetracycline-Rabeprazole Triple

Also known as: Tetracycline, Rabeprazole

Bismuth Quadruple Therapy; Bismuth-Tetracycline-Rabeprazole Triple Therapy

Bismuth quadruple therapy DRUG

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

Also known as: Rabeprazole, Tetracycline, Metronidazole

Bismuth Quadruple Therapy; Bismuth-Tetracycline-Rabeprazole Triple Therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chih-An Shih, MD: lead

Study Sites (1)

Antai Medical Care Corporation, Antai Tian-Sheng Memorial Hospital

Pingtung City, 928004, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 38906695 RESULT

• 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.

  PMID: 36650673 RESULT

MeSH Terms

Interventions

Bismuth; Tetracycline; Rabeprazole; Metronidazole

Intervention Hierarchy (Ancestors)

Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Study Officials

• Chih-An Shih, Doctor of Medicine

  Antai Medical Care Corporation, Antai Tian-Sheng Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chih-An Shih, Doctor of Medicine

CONTACT

886-8-8329966; dreric921@gmail.com

Chang-Yi Li, Bachelor

CONTACT

886-8-8329966; victorlee0702@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Antai Medical Care Corporation, Antai Tian-Sheng Memorial Hospital

Model Details: In this single-center, randomized, open-label trial, we will enroll 300 adults infected with Helicobacter pylori. Subjects will be randomly assigned using a computer-generated randomization sequence (1:1 ratio) to receive one of the following treatments: (1) a 14-day combination therapy of bismuth-tetracycline-rabeprazole, or (2) a 14-day combination therapy of bismuth-rabeprazole-tetracycline-metronidazole.

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)