Helicobatcer PyloriNCT07788053
Efficacy And Safety of Bismuth-Tetracycline-Rabeprazole Triple For First-Line Eradication of Helicobacter Pylori Infection
A study testing Bismuth and Bismuth quadruple therapy in people with Helicobatcer Pylori and First-Line Eradication, run by Chih-An Shih, MD at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Helicobatcer Pylori, First-Line Eradication
- What is being tested?
- Bismuth and Bismuth quadruple therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2026to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Antai Medical Care Corporation, Antai Tian-Sheng Memorial Hospital
Pingtung City, 928004
About this study
Official title: 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.
- Conditions
- Helicobatcer Pylori, First-Line Eradication
- Being tested
- Bismuth, Bismuth quadruple therapy
- Keywords
- bismuth, triple therapy, tetracycline, proton pump inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BismuthDrug
Also called Tetracycline, Rabeprazole
14-day Bismuth-Tetracycline-Rabeprazole Triple
Bismuth quadruple therapyDrug
Also called Rabeprazole, Tetracycline, Metronidazole
Bismuth quadruple therapy, combining Rabeprazole, Tetracycline, Bismuth, and Metronidazole
| Study group | Role | What they receive |
|---|---|---|
| Bismuth-Tetracycline-Rabeprazole Triple Therapy | Active comparator | Bismuth、Tetracycline、Rabeprazole Receives: Drug: Bismuth; Drug: Bismuth quadruple therapy |
| Bismuth Quadruple Therapy | Active comparator | Bismuth、Tetracycline、Rabeprazol、Metronidazole Receives: Drug: Bismuth; Drug: Bismuth quadruple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Helicobatcer PyloriStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chih-An Shih, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chih-An Shih, MD, Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Ta
- Investigators
- Chih-An Shih, Doctor of Medicine, Principal investigator, Antai Medical Care Corporation, Antai Tian-Sheng Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788053
- Sponsor's protocol ID
- AntaiMedCare
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 38906695Gao 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07788053
- Acronym / sponsor ID
- AntaiMedCare
- Conditions
- Helicobatcer Pylori, First-Line Eradication
- Keywords
- bismuth, triple therapy, tetracycline, proton pump inhibitor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chih-An Shih, MDUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bismuth-Tetracycline-Rabeprazole Triple Therapy | Active comparator | Drug: Bismuth, Drug: Bismuth quadruple therapyBismuth、Tetracycline、Rabeprazole |
| Bismuth Quadruple Therapy | Active comparator | Drug: Bismuth, Drug: Bismuth quadruple therapyBismuth、Tetracycline、Rabeprazol、Metronidazole |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BismuthAlso: Tetracycline, Rabeprazole14-day Bismuth-Tetracycline-Rabeprazole Triple | Drug | Bismuth Quadruple Therapy, Bismuth-Tetracycline-Rabeprazole Triple Therapy |
| Bismuth quadruple therapyAlso: Rabeprazole, Tetracycline, MetronidazoleBismuth quadruple therapy, combining Rabeprazole, Tetracycline, Bismuth, and Metronidazole | Drug | Bismuth Quadruple Therapy, Bismuth-Tetracycline-Rabeprazole Triple Therapy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Results publication: PubMed 38906695Gao 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.
- Results publication: PubMed 36650673Gao 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chih-An Shih, Doctor of Medicine principal investigator
Antai Medical Care Corporation, Antai Tian-Sheng Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bismuth and Bismuth quadruple therapy in people with Helicobatcer Pylori and First-Line Eradication, run by Chih-An Shih, MD at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chih-An Shih, Doctor of Medicine (886-8-8329966, dreric921@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eradication rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07788053, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.