HELICOBACTER PYLORI INFECTIONSPhase 4NCT06723197
Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication
A Phase 4 study testing vonoprazan+amoxicillin, Duration of eradication regimen: 7-day and vonoprazan+amoxicillin+tetracycline+bismuth in people with HELICOBACTER PYLORI INFECTIONS, run by Shandong University at 1 site in China.
Trial summary
The study aimed to compare the efficacy and safety of dual and quadruple regimens with different durations (7-day, 10-day, 14-day) for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. 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?
- vonoprazan+amoxicillin, Duration of eradication regimen: 7-day and vonoprazan+amoxicillin+tetracycline+bismuth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2024to 30 Nov 2025
- Phase
- Phase 4
- 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
Who may be able to join
- Patients aged 18-70 years old
- Patients with H.pylori infection (13C/14C-urea breath test)
- Patients without previous treatment for H. pylori eradication
Who cannot join
- Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%
- Patients with active gastrointestinal bleeding
- Patients with a history of upper gastrointestinal surgery
- Patients allergic to treatment drugs
- Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks
- Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial
- 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, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Yueyue Li, +86-18560089751, lyynqj@126.com
About this study
Official title: Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication: a Multicentre, Randomised, Controlled Trial
The study aimed to compare the efficacy and safety of dual and quadruple regimens with different durations (7-day, 10-day, 14-day) for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- vonoprazan+amoxicillin, Duration of eradication regimen: 7-day, vonoprazan+amoxicillin+tetracycline+bismuth, Duration of eradication regimen: 10-day, Duration of eradication regimen: 14-day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vonoprazan+amoxicillinDrug
Drug combinations for dual regimens：vonoprazan+amoxicillin
Duration of eradication regimen: 7-dayOther
Duration of eradication regimen: 7-day
vonoprazan+amoxicillin+tetracycline+bismuthDrug
Drug combinations for quadruple regimens: vonoprazan+amoxicillin+tetracycline+bismuth
Duration of eradication regimen: 10-dayOther
Duration of eradication regimen: 10-day
Duration of eradication regimen: 14-dayOther
Duration of eradication regimen: 14-day
| Study group | Role | What they receive |
|---|---|---|
| 14-day dual regimen | Active comparator | Not described Receives: Drug: vonoprazan+amoxicillin; Other: Duration of eradication regimen: 14-day |
| 10-day dual regimen | Experimental | Not described Receives: Drug: vonoprazan+amoxicillin; Other: Duration of eradication regimen: 10-day |
| 7-day quadruple regimen | Experimental | Not described Receives: Other: Duration of eradication regimen: 7-day; Drug: vonoprazan+amoxicillin+tetracycline+bismuth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
13C-urea breath test was used to determine whether eradication was successful. Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in the three groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Measured: Six weeks after treatment
Secondary outcomes (2)
Rate of adverse reactions
Drug-related adverse reactions needs to be recorded after treatment
Measured: Immediately after treatment
Patient compliance
The number of missed and overdosed doses of medication needs to be completed after treatment.
Measured: Immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start10 Dec 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Zibo Maternal and Child Health Hospital, Zaozhuang Municipal Hospital, Feicheng Municipal People's Hospital, Shandong University of Traditional Chinese Medicine, The People's Hospital of Jimo.Qingdao, Dezhou Hospital Qilu Hospital of Shandong University
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723197
- Sponsor's protocol ID
- 202411
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qian HS, Li WJ, Dang YN, Li LR, Xu XB, Yuan L, Zhang WF, Yang Z, Gao X, Zhang M, Li X, Zhang GX. Ten-Day Vonoprazan-Amoxicillin Dual Therapy as a First-Line Treatment of Helicobacter pylori Infection Compared With Bismuth-Containing Quadruple Therapy. Am J Gastroenterol. 2023 Apr 1;118(4):627-634. doi: 10.14309/ajg.0000000000002086. Epub 2022 Dec 2.
PubMed 36729890Du RC, Hu YX, Ouyang Y, Ling LX, Xu JY, Sa R, Liu XS, Hong JB, Zhu Y, Lu NH, Hu Y. Vonoprazan and amoxicillin dual therapy as the first-line treatment of Helicobacter pylori infection: A systematic review and meta-analysis. Helicobacter. 2024 Jan-Feb;29(1):e13039. doi: 10.1111/hel.13039. Epub 2023 Nov 30.
PubMed 38036941Zhou L, Lu H, Song Z, Lyu B, Chen Y, Wang J, Xia J, Zhao Z; on behalf of Helicobacter Pylori Study Group of Chinese Society of Gastroenterology. 2022 Chinese national clinical practice guideline on Helicobacter pylori eradication treatment. Chin Med J (Engl). 2022 Dec 20;135(24):2899-2910. doi: 10.1097/CM9.0000000000002546.
PubMed 36579940Crowe SE. Helicobacter pylori Infection. N Engl J Med. 2019 Mar 21;380(12):1158-1165. doi: 10.1056/NEJMcp1710945. No abstract available.
PubMed 30893536Li Y, Choi H, Leung K, Jiang F, Graham DY, Leung WK. Global prevalence of Helicobacter pylori infection between 1980 and 2022: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2023 Jun;8(6):553-564. doi: 10.1016/S2468-1253(23)00070-5. Epub 2023 Apr 20.
PubMed 37086739Ju K, Zhao H, Guo L, Zhai Z, Song X, Zhao H, Zhang W, Li X, Zhang H, Xia W, Zheng R, Liu S, Sun L, Ding R, Liu X, Teng T, Kong Q, Li Y, Zuo X, Li Y. Vonoprazan-Based Dual and Quadruple Therapy with Varying Duration for Helicobacter pylori Eradication: A Multicenter, Randomized Controlled Trial. Int J Antimicrob Agents. 2026 Jul 31:107948. doi: 10.1016/j.ijantimicag.2026.107948. Online ahead of print.
PubMed 42537821
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication: a Multicentre, Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT06723197
- Acronym / sponsor ID
- 202411
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Zibo Maternal and Child Health Hospital, Zaozhuang Municipal Hospital, Feicheng Municipal People's Hospital, Shandong University of Traditional Chinese Medicine, The People's Hospital of Jimo.Qingdao, Dezhou Hospital Qilu Hospital of Shandong University
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 9 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.
The study aimed to compare the efficacy and safety of dual and quadruple regimens with different durations (7-day, 10-day, 14-day) for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 14-day dual regimen | Active comparator | Drug: vonoprazan+amoxicillin, Other: Duration of eradication regimen: 14-day |
| 10-day dual regimen | Experimental | Drug: vonoprazan+amoxicillin, Other: Duration of eradication regimen: 10-day |
| 7-day quadruple regimen | Experimental | Other: Duration of eradication regimen: 7-day, Drug: vonoprazan+amoxicillin+tetracycline+bismuth |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-70 years old
- Patients with H.pylori infection (13C/14C-urea breath test)
- Patients without previous treatment for H. pylori eradication
Key exclusion criteria (8 listed)
- Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%
- Patients with active gastrointestinal bleeding
- Patients with a history of upper gastrointestinal surgery
- Patients allergic to treatment drugs
- Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks
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 |
|---|---|---|
| vonoprazan+amoxicillinDrug combinations for dual regimens：vonoprazan+amoxicillin | Drug | 10-day dual regimen, 14-day dual regimen |
| Duration of eradication regimen: 7-dayDuration of eradication regimen: 7-day | Other | 7-day quadruple regimen |
| vonoprazan+amoxicillin+tetracycline+bismuthDrug combinations for quadruple regimens: vonoprazan+amoxicillin+tetracycline+bismuth | Drug | 7-day quadruple regimen |
| Duration of eradication regimen: 10-dayDuration of eradication regimen: 10-day | Other | 10-day dual regimen |
| Duration of eradication regimen: 14-dayDuration of eradication regimen: 14-day | Other | 14-day dual regimen |
Primary outcome
Eradication rate
Time frame: Six weeks after treatment
13C-urea breath test was used to determine whether eradication was successful. Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in the three groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
2 secondary outcomes
Rate of adverse reactions
Time frame: Immediately after treatment
Patient compliance
Time frame: Immediately after treatment
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 11 Dec 2024.
- Results publication: PubMed 36729890Qian HS, Li WJ, Dang YN, Li LR, Xu XB, Yuan L, Zhang WF, Yang Z, Gao X, Zhang M, Li X, Zhang GX. Ten-Day Vonoprazan-Amoxicillin Dual Therapy as a First-Line Treatment of Helicobacter pylori Infection Compared With Bismuth-Containing Quadruple Therapy. Am J Gastroenterol. 2023 Apr 1;118(4):627-634. doi: 10.14309/ajg.0000000000002086. Epub 2022 Dec 2.
- Results publication: PubMed 38036941Du RC, Hu YX, Ouyang Y, Ling LX, Xu JY, Sa R, Liu XS, Hong JB, Zhu Y, Lu NH, Hu Y. Vonoprazan and amoxicillin dual therapy as the first-line treatment of Helicobacter pylori infection: A systematic review and meta-analysis. Helicobacter. 2024 Jan-Feb;29(1):e13039. doi: 10.1111/hel.13039. Epub 2023 Nov 30.
- Results publication: PubMed 36579940Zhou L, Lu H, Song Z, Lyu B, Chen Y, Wang J, Xia J, Zhao Z; on behalf of Helicobacter Pylori Study Group of Chinese Society of Gastroenterology. 2022 Chinese national clinical practice guideline on Helicobacter pylori eradication treatment. Chin Med J (Engl). 2022 Dec 20;135(24):2899-2910. doi: 10.1097/CM9.0000000000002546.
- Results publication: PubMed 30893536Crowe SE. Helicobacter pylori Infection. N Engl J Med. 2019 Mar 21;380(12):1158-1165. doi: 10.1056/NEJMcp1710945. No abstract available.
- Results publication: PubMed 37086739Li Y, Choi H, Leung K, Jiang F, Graham DY, Leung WK. Global prevalence of Helicobacter pylori infection between 1980 and 2022: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2023 Jun;8(6):553-564. doi: 10.1016/S2468-1253(23)00070-5. Epub 2023 Apr 20.
- Derived from this study: PubMed 42537821Ju K, Zhao H, Guo L, Zhai Z, Song X, Zhao H, Zhang W, Li X, Zhang H, Xia W, Zheng R, Liu S, Sun L, Ding R, Liu X, Teng T, Kong Q, Li Y, Zuo X, Li Y. Vonoprazan-Based Dual and Quadruple Therapy with Varying Duration for Helicobacter pylori Eradication: A Multicenter, Randomized Controlled Trial. Int J Antimicrob Agents. 2026 Jul 31:107948. doi: 10.1016/j.ijantimicag.2026.107948. Online ahead of print.
- Individual participant dataSharing planned: No
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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?
A Phase 4 study testing vonoprazan+amoxicillin, Duration of eradication regimen: 7-day and vonoprazan+amoxicillin+tetracycline+bismuth in people with HELICOBACTER PYLORI INFECTIONS, run by Shandong University 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: looking for participants now, as of the sponsor's last update on 11 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yanqing Li, Ph.D (+8653188369277, liyanqing@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: Six weeks after treatment). 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 NCT06723197, which also lists 6 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 11 Dec 2024.