Helicobacter Pylori InfectionSHARE2401NCT06299605

Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori

A study testing Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days, Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days and Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days in people with Helicobacter Pylori Infection, run by Shandong University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Helicobacter Pylori Infection
What is being tested?: Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days, Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days and Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 375 participants
Where: 1 siteChina
Study dates: 27 Nov 2024to 30 Nov 2025
Phase: Interventional
Are there results?: None posted in the registry

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 (positive rapid urease test, 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.

China1 site

Qilu Hospital of Shandong University
Jinan, Shandong, 250000

Other trials in China

About this study

Official title: Triple Versus Quadruple Therapy with Amoxicillin and Tetracycline for the Eradication of Helicobacter Pylori: a Multicenter Randomized Controlled Trial

The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy 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.

Read the detailed description

pylori-positive patients without eradication history were recruited according to inclusion and exclusion criteria and randomized to the intervention:

14-day quadruple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days 14-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 14 days 7-day triple regimen: Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid 7 days Subjects were asked to record adverse events and 6 weeks after treatment, 13C-urea breath test was tested for confirmation. The eradication rates, adverse reaction rates and patient adherence were calculated and analysed, and the results were analysed to provide more information for eradication regimens of H. pylori.

Conditions: Helicobacter Pylori Infection
Being tested: Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days, Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days, Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 daysDrug
Also called Vonoprazan, Amoxicillin, Tetracycline, Bismuth
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days
Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 daysDrug
Also called Vonoprazan, Amoxicillin, Tetracycline, 14 days
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days
Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 daysDrug
Also called Vonoprazan, Amoxicillin, Tetracycline, 7 days
Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days

Study groups in NCT06299605
Study group	Role	What they receive
14-day quadruple regimen	Active comparator	Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days Receives: Drug: Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days
14-day triple regimen	Experimental	Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days Receives: Drug: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days
7-day triple regimen	Experimental	Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days Receives: Drug: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days

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: Immediately after follow-up check

Secondary outcomes (2)

Rate of adverse reactions
A questionnaire on drug-related adverse reactions needs to be completed after treatment.
Measured: Immediately after follow-up check
Patient compliance
A questionnaire on the number of missed and overdosed doses of medication needs to be completed after treatment. Good compliance was defined as taking 80%-120% of the pills.
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.

27 Nov 202430 Nov 2025

First posted8 Mar 2024
Study start27 Nov 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 (8)Papers the sponsor has linked to this study.
Other trials for Helicobacter Pylori InfectionStudies 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
Masking: None (open label)
Enrolment: 375 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06299605
Sponsor's protocol ID: SHARE2401
Acronym: SHARE2401
Status last verified: Mar 2024
First submitted: 19 Feb 2024
Last updated: 3 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Li 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 37086739
Crowe SE. Helicobacter pylori Infection. N Engl J Med. 2019 Mar 21;380(12):1158-1165. doi: 10.1056/NEJMcp1710945. No abstract available.
PubMed 30893536
Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 11;71(9):1724-1762. doi: 10.1136/gutjnl-2022-327745.
PubMed 35944925
Lin K, Huang L, Wang Y, Li K, Ye Y, Yang S, Li A. Efficacy of genotypic susceptibility-guided tailored therapy for Helicobacter pylori infection: A systematic review and single arm meta-analysis. Helicobacter. 2023 Dec;28(6):e13015. doi: 10.1111/hel.13015. Epub 2023 Aug 27.
PubMed 37634236
Savoldi A, Carrara E, Graham DY, Conti M, Tacconelli E. Prevalence of Antibiotic Resistance in Helicobacter pylori: A Systematic Review and Meta-analysis in World Health Organization Regions. Gastroenterology. 2018 Nov;155(5):1372-1382.e17. doi: 10.1053/j.gastro.2018.07.007. Epub 2018 Jul 7.
PubMed 29990487
Jiang Z, Qian X, Wang Z, Dong Y, Pan Y, Zhang Z, Wang S. Antibiotic resistance of Helicobacter pylori isolated from patients in Nanjing, China: A cross-section study from 2018 to 2021. Front Cell Infect Microbiol. 2022 Sep 8;12:970630. doi: 10.3389/fcimb.2022.970630. eCollection 2022.
PubMed 36159644
Chey WD, Megraud F, Laine L, Lopez LJ, Hunt BJ, Howden CW. Vonoprazan Triple and Dual Therapy for Helicobacter pylori Infection in the United States and Europe: Randomized Clinical Trial. Gastroenterology. 2022 Sep;163(3):608-619. doi: 10.1053/j.gastro.2022.05.055. Epub 2022 Jun 6.
PubMed 35679950
Xie Y, Hu Y, Zhu Y, Wang H, Wang QZ, Li YQ, Wang JB, Zhang ZY, Zhang DK, Liu XW, Lu NH. Colloidal bismuth pectin-containing quadruple therapy as the first-line treatment of Helicobacter pylori infection: A multicenter, randomized, double-blind, non-inferiority clinical trial. Helicobacter. 2023 Jun;28(3):e12978. doi: 10.1111/hel.12978. Epub 2023 Mar 31.
PubMed 37002653

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
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Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
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All Helicobacter Pylori Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Triple Versus Quadruple Therapy with Amoxicillin and Tetracycline for the Eradication of Helicobacter Pylori: a Multicenter Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06299605
Acronym / sponsor ID: SHARE2401 / SHARE2401
Conditions: Helicobacter Pylori Infection
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 375 participants (estimated)
Lead sponsor: Shandong UniversityUniversity, hospital or other
Collaborators: Binzhou Maternal and Child Health Hospital, Zibo Maternal and Child Health Hospital, Zaozhuang Municipal Hospital, Linyi People's Hospital, Feicheng Municipal People's Hospital
Study start: 27 Nov 2024 (actual)
Primary completion: 1 Oct 2025 (estimated)
Study completion: 30 Nov 2025 (estimated)
First posted: 8 Mar 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.

Detailed description

pylori-positive patients without eradication history were recruited according to inclusion and exclusion criteria and randomized to the intervention:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
14-day quadruple regimen	Active comparator	Drug: Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 daysVonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days
14-day triple regimen	Experimental	Drug: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 daysVonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days
7-day triple regimen	Experimental	Drug: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 daysVonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days

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 (positive rapid urease test, 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-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 daysAlso: Vonoprazan, Amoxicillin, Tetracycline, BismuthVonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days	Drug	14-day quadruple regimen
Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 daysAlso: Vonoprazan, Amoxicillin, Tetracycline, 14 daysVonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days	Drug	14-day triple regimen
Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 daysAlso: Vonoprazan, Amoxicillin, Tetracycline, 7 daysVonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days	Drug	7-day triple regimen

Primary outcome

Eradication rate
Time frame: Immediately after follow-up check
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 follow-up check
Patient compliance
Time frame: Immediately after follow-up check

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
Background: 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.
Background: PubMed 30893536Crowe SE. Helicobacter pylori Infection. N Engl J Med. 2019 Mar 21;380(12):1158-1165. doi: 10.1056/NEJMcp1710945. No abstract available.
Background: PubMed 35944925Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 11;71(9):1724-1762. doi: 10.1136/gutjnl-2022-327745.
Background: PubMed 37634236Lin K, Huang L, Wang Y, Li K, Ye Y, Yang S, Li A. Efficacy of genotypic susceptibility-guided tailored therapy for Helicobacter pylori infection: A systematic review and single arm meta-analysis. Helicobacter. 2023 Dec;28(6):e13015. doi: 10.1111/hel.13015. Epub 2023 Aug 27.
Background: PubMed 29990487Savoldi A, Carrara E, Graham DY, Conti M, Tacconelli E. Prevalence of Antibiotic Resistance in Helicobacter pylori: A Systematic Review and Meta-analysis in World Health Organization Regions. Gastroenterology. 2018 Nov;155(5):1372-1382.e17. doi: 10.1053/j.gastro.2018.07.007. Epub 2018 Jul 7.
Background: PubMed 36159644Jiang Z, Qian X, Wang Z, Dong Y, Pan Y, Zhang Z, Wang S. Antibiotic resistance of Helicobacter pylori isolated from patients in Nanjing, China: A cross-section study from 2018 to 2021. Front Cell Infect Microbiol. 2022 Sep 8;12:970630. doi: 10.3389/fcimb.2022.970630. eCollection 2022.
Background: PubMed 35679950Chey WD, Megraud F, Laine L, Lopez LJ, Hunt BJ, Howden CW. Vonoprazan Triple and Dual Therapy for Helicobacter pylori Infection in the United States and Europe: Randomized Clinical Trial. Gastroenterology. 2022 Sep;163(3):608-619. doi: 10.1053/j.gastro.2022.05.055. Epub 2022 Jun 6.
Background: PubMed 37002653Xie Y, Hu Y, Zhu Y, Wang H, Wang QZ, Li YQ, Wang JB, Zhang ZY, Zhang DK, Liu XW, Lu NH. Colloidal bismuth pectin-containing quadruple therapy as the first-line treatment of Helicobacter pylori infection: A multicenter, randomized, double-blind, non-inferiority clinical trial. Helicobacter. 2023 Jun;28(3):e12978. doi: 10.1111/hel.12978. Epub 2023 Mar 31.
Individual participant dataSharing planned: No

Related trials for Helicobacter Pylori Infection

RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
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Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: status not confirmed, as of the sponsor's last update on 3 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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?

On the ClinicalTrials.gov record for NCT06299605, which also lists 8 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 3 Dec 2024.