HELICOBACTER PYLORI INFECTIONSNCT06731023
Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study
An observational study of HELICOBACTER PYLORI INFECTIONS, run by Xiuli Zuo at 1 site in China.
Trial summary
Helicobacter pylori (H. pylori) infection, a prevalent global infectious disease, is a significant contributor to gastric cancer and other morbidities, imposing a substantial disease burden. With the rise in antibiotic resistance, the eradication of H. pylori is encountering formidable challenges. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- Bismuth, Vonoprazan and Amoxicillin
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study enrolled patients with extremely refractory Helicobacter pylori (H. pylori) infection, identified in the outpatient department. These patients had previously undergone eradication programs that included three antibiotics with low resistance rates: amoxicillin, tetracycline, and furazolidone. Despite this, reexamination confirmed persistent H. pylori infection. Upon entry into the study, participants were required to fulfill the inclusion criteria, not meet the exclusion criteria, and provide signed informed consent.
Who may be able to join
- Patients aged 18-65.
- Patients with H.pylori infection (Positive for rapid urease test or 13C urea breath test).
- Received at least two previous standard treatment protocols for Helicobacter pylori, and the application regimens included at least three low-resistance antibiotics.
Who cannot join
- Patients with serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
- Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
- Patients with active gastrointestinal bleeding.
- Patients with a history of upper gastrointestinal surgery.
- Patients allergic to treatment drugs.
- Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
- Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
- Patients who are unwilling or incapable to provide informed consents.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xiuli Zuo, MD,PhD, 15588818685, zuoxiuli@sdu.edu.cn
About this study
Helicobacter pylori (H. pylori) infection, a prevalent global infectious disease, is a significant contributor to gastric cancer and other morbidities, imposing a substantial disease burden. With the rise in antibiotic resistance, the eradication of H. pylori is encountering formidable challenges. A subset of individuals, despite undergoing multiple treatment regimens, remain unable to successfully eradicate the infection. The persistence of infection in these cases could be attributed to either the limitations of detection methods leading to false positives or to the infection by superbugs that are highly resistant to antibiotics. This study is designed to ascertain whether these patients are infected with superbugs by employing various diagnostic techniques. Additionally, it aims to assess the antibiotic resistance profiles of strains associated with extremely refractory H. pylori infections through drug susceptibility testing. Based on the identified sensitivities, the study seeks to tailor treatment protocols with bismuth-containing quadruple therapy (Containing two kinds of antibiotics: sensitive antibiotic, rifabutin or high-dose metronidazole), to explore novel therapeutic strategies for patients with highly resistant H. pylori infections.
Read the detailed description
The study enrolled patients with extremely refractory Helicobacter pylori (H. pylori) infection, identified in the outpatient department. Following enrollment, a comprehensive diagnostic approach was employed to ascertain the presence of H. pylori infection and to rule out false positives. Patients who test truly positive for H. pylori should undergo eradication therapy, avoiding any previously administered regimens. For those with unsuccessful culture attempts, a bismuth-containing quadruple therapy (vonoprazan + bismuth + amoxicillin + rifabutin) is recommended as an exploratory approach. Patients with successful cultures should undergo drug susceptibility testing to identify antibiotic resistance patterns of the H. pylori strain. Based on these results, a 14-day course of bismuth-containing quadruple eradication therapy is prescribed. Patients with strains that demonstrate sensitivity to both amoxicillin and rifabutin are assigned to the bismuth-containing quadruple therapy group (vonoprazan + bismuth + amoxicillin + rifabutin). For other patients, two non-resistant antibiotics are selected based on drug susceptibility test outcomes. If a patient shows sensitivity to only one antibiotic, a combination of that sensitive antibiotic with high-dose metronidazole is administered. After eradication treatment, 13C urea breath test and fecal antigen detection were re-examined 4 weeks after drug withdrawal.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- Bismuth, Vonoprazan, Amoxicillin, Rifabutin, Metronidazole
- Keywords
- Helicobacter pylori, Bismuth-Containing Quadruple Therapy, Drug Susceptibility Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BismuthDrug
Bismuth 0.6g bid
VonoprazanDrug
vonoprazan 20mg bid
AmoxicillinDrug
Amoxicillin 1g bid
RifabutinDrug
Rifabutin 0.15g bid
MetronidazoleDrug
Metronidazole 400mg qid
Other antibioticsDrug
The selection of other antibiotics is based on the results of drug susceptibility testing.
| Study group | Role | What they receive |
|---|---|---|
| Unsuccessful culture attempts group | Bismuth-containing quadruple therapy (vonoprazan 20 mg bid + bismuth 0.6g bid + amoxicillin 1g bid + rifabutin 0.15g bid) Receives: Drug: Bismuth; Drug: Vonoprazan; Drug: Amoxicillin; Drug: Rifabutin | |
| Demonstrate sensitivity to both amoxicillin and rifabutin group | Bismuth-containing quadruple therapy (vonoprazan 20 mg bid + bismuth 0.6g bid + amoxicillin 1g bid + rifabutin 0.15g bid) Receives: Drug: Bismuth; Drug: Vonoprazan; Drug: Amoxicillin; Drug: Rifabutin | |
| Drug susceptibility testing group | Two non-resistant antibiotics are selected based on drug susceptibility testing outcomes. If a patient shows sensitivity to only one antibiotic, a combination of that sensitive antibiotic with high-dose metronidazole is administered. Receives: Drug: Bismuth; Drug: Vonoprazan; Drug: Amoxicillin; Drug: Rifabutin; Drug: Metronidazole; Drug: Other antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
Measured: Immediately after follow-up check.
Secondary outcomes (4)
Rate of adverse reactions.
Measured: Immediately after follow-up check.
False positive rate
The false positive rate is defined as the proportion of patients whose only C13 breath test results are positive and any other test is negative.
Measured: Immediately after follow-up check.
Patient compliance
Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.
Measured: Immediately after follow-up check.
Cost-effectiveness index
Ratio of costs to effectiveness
Measured: Immediately after follow-up check.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiuli Zuo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiuli Zuo, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731023
- Sponsor's protocol ID
- KYLL-202410-006-1
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study
- ClinicalTrials.gov ID
- NCT06731023
- Acronym / sponsor ID
- KYLL-202410-006-1
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Keywords
- Helicobacter pylori, Bismuth-Containing Quadruple Therapy, Drug Susceptibility Testing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xiuli ZuoUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Dec 2024 (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.
Helicobacter pylori (H. pylori) infection, a prevalent global infectious disease, is a significant contributor to gastric cancer and other morbidities, imposing a substantial disease burden. With the rise in antibiotic resistance, the eradication of H. pylori is encountering formidable challenges. A subset of individuals, despite undergoing multiple treatment regimens, remain unable to successfully eradicate the infection. The persistence of infection in these cases could be attributed to either the limitations of detection methods leading to false positives or to the infection by superbugs that are highly resistant to antibiotics. This study is designed to ascertain whether these patients are infected with superbugs by employing various diagnostic techniques. Additionally, it aims to assess the antibiotic resistance profiles of strains associated with extremely refractory H. pylori infections through drug susceptibility testing. Based on the identified sensitivities, the study seeks to tailor treatment protocols with bismuth-containing quadruple therapy (Containing two kinds of antibiotics: sensitive antibiotic, rifabutin or high-dose metronidazole), to explore novel therapeutic strategies for patients with highly resistant H. pylori infections.
Detailed description
The study enrolled patients with extremely refractory Helicobacter pylori (H. pylori) infection, identified in the outpatient department. Following enrollment, a comprehensive diagnostic approach was employed to ascertain the presence of H. pylori infection and to rule out false positives. Patients who test truly positive for H. pylori should undergo eradication therapy, avoiding any previously administered regimens. For those with unsuccessful culture attempts, a bismuth-containing quadruple therapy (vonoprazan + bismuth + amoxicillin + rifabutin) is recommended as an exploratory approach. Patients with successful cultures should undergo drug susceptibility testing to identify antibiotic resistance patterns of the H. pylori strain. Based on these results, a 14-day course of bismuth-containing quadruple eradication therapy is prescribed. Patients with strains that demonstrate sensitivity to both amoxicillin and rifabutin are assigned to the bismuth-containing quadruple therapy group (vonoprazan + bismuth + amoxicillin + rifabutin). For other patients, two non-resistant antibiotics are selected based on drug susceptibility test outcomes. If a patient shows sensitivity to only one antibiotic, a combination of that sensitive antibiotic with high-dose metronidazole is administered. After eradication treatment, 13C urea breath test and fecal antigen detection were re-examined 4 weeks after drug withdrawal.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unsuccessful culture attempts group | – | Drug: Bismuth, Drug: Vonoprazan, Drug: Amoxicillin, Drug: RifabutinBismuth-containing quadruple therapy (vonoprazan 20 mg bid + bismuth 0.6g bid + amoxicillin 1g bid + rifabutin 0.15g bid) |
| Demonstrate sensitivity to both amoxicillin and rifabutin group | – | Drug: Bismuth, Drug: Vonoprazan, Drug: Amoxicillin, Drug: RifabutinBismuth-containing quadruple therapy (vonoprazan 20 mg bid + bismuth 0.6g bid + amoxicillin 1g bid + rifabutin 0.15g bid) |
| Drug susceptibility testing group | – | Drug: Bismuth, Drug: Vonoprazan, Drug: Amoxicillin, Drug: Rifabutin, Drug: Metronidazole, Drug: Other antibioticsTwo non-resistant antibiotics are selected based on drug susceptibility testing outcomes. If a patient shows sensitivity to only one antibiotic, a combination of that sensitive antibiotic with high-dose metronidazole is administered. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study enrolled patients with extremely refractory Helicobacter pylori (H. pylori) infection, identified in the outpatient department. These patients had previously undergone eradication programs that included three antibiotics with low resistance rates: amoxicillin, tetracycline, and furazolidone. Despite this, reexamination confirmed persistent H. pylori infection. Upon entry into the study, participants were required to fulfill the inclusion criteria, not meet the exclusion criteria, and provide signed informed consent.
Key inclusion criteria (3 listed)
- Patients aged 18-65.
- Patients with H.pylori infection (Positive for rapid urease test or 13C urea breath test).
- Received at least two previous standard treatment protocols for Helicobacter pylori, and the application regimens included at least three low-resistance antibiotics.
Key exclusion criteria (8 listed)
- Patients with serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
- Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
- Patients with active gastrointestinal bleeding.
- Patients with a history of upper gastrointestinal surgery.
- Patients allergic to treatment drugs.
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 |
|---|---|---|
| BismuthBismuth 0.6g bid | Drug | Demonstrate sensitivity to both amoxicillin and rifabutin group, Drug susceptibility testing group, Unsuccessful culture attempts group |
| Vonoprazanvonoprazan 20mg bid | Drug | Demonstrate sensitivity to both amoxicillin and rifabutin group, Drug susceptibility testing group, Unsuccessful culture attempts group |
| AmoxicillinAmoxicillin 1g bid | Drug | Demonstrate sensitivity to both amoxicillin and rifabutin group, Drug susceptibility testing group, Unsuccessful culture attempts group |
| RifabutinRifabutin 0.15g bid | Drug | Demonstrate sensitivity to both amoxicillin and rifabutin group, Drug susceptibility testing group, Unsuccessful culture attempts group |
| MetronidazoleMetronidazole 400mg qid | Drug | Drug susceptibility testing group |
| Other antibioticsThe selection of other antibiotics is based on the results of drug susceptibility testing. | Drug | Drug susceptibility testing group |
Primary outcome
Eradication rate
Time frame: Immediately after follow-up check.
4 secondary outcomes
Rate of adverse reactions.
Time frame: Immediately after follow-up check.
False positive rate
Time frame: Immediately after follow-up check.
Patient compliance
Time frame: Immediately after follow-up check.
Cost-effectiveness index
Time frame: Immediately after follow-up check.
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 19 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HELICOBACTER PYLORI INFECTIONS, run by Xiuli Zuo at 1 site in China.
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 3 inclusion and 8 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 19 Dec 2024. 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 China. 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 Xiuli Zuo, MD,PhD (15588818685, zuoxiuli@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate (time frame: Immediately after follow-up check.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2024.