HELICOBACTER PYLORI INFECTIONSRETROHPNCT07121205
High-Dose Dual Therapy for H. Pylori Eradication (RETRO-HP Study)
An observational study of HELICOBACTER PYLORI INFECTIONS, run by Liyueyue at 1 site in China.
Trial summary
Background: High-dose dual therapy (HDDT) has emerged as a potential first-line treatment for Helicobacter pylori infection, but its efficacy and safety across different regimens and populations remain unclear. 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?
- This study is a retrospective study, and all data have been collected in advance with no active intervention required.
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 20 Jul 2025
- Phase
- Observational
- 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
Study population: (1) patients aged 18-70 years, regardless of gender; (2) absent history of receiving H. pylori eradication therapy; (3) diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.
Who may be able to join
- (1) patients aged 18-70 years, regardless of gender; (2) absent history of receiving H. pylori eradication therapy; (3) diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.
Who cannot join
- (1) patients with incomplete medical records, including missing treatment details, absence of post-treatment follow-up test results, or failure to complete essential follow-up assessments; (2) patients who received treatment regimens that did not conform to the standardized HDDT protocol specified in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China.
Jinan, Shandong, Wenhuaxilu
About this study
Official title: Comparative Analysis of High-Dose Dual Therapies in First-Line Helicobacter Pylori Eradication: A Multicenter Retrospective Study
Background:
High-dose dual therapy (HDDT) has emerged as a potential first-line treatment for Helicobacter pylori infection, but its efficacy and safety across different regimens and populations remain unclear. This study aimed to compare real-world outcomes of various HDDT protocols and identify factors influencing treatment failure.
Read more
Methods:
A multicenter retrospective analysis was conducted using data from 15 medical centers (January 2022-January 2025). Patients received one of four HDDT regimens: vonoprazan-amoxicillin for 10 days (VA-10) or 14 days (VA-14), esomeprazole-amoxicillin (EA), or tegoprazan-amoxicillin (TA). Primary outcomes included eradication rates (modified intention-to-treat analysis) and adverse events.
Read the detailed description
This study is a multicenter, retrospective, observational study utilizing medical records of outpatients who received standard high-dose dual therapy (HDDT) for Helicobacter pylori eradication between January 2022 and January 2025. The aim was to compare the efficacy and adverse event rates of different HDDT regimens.
Collected data included:
Baseline demographics (age, sex, etc.)
Medical/lifestyle history
Treatment regimens
Adverse events
Compliance
All data were anonymized at collection, and no additional patient contact or information collection was required. Since this study involved only retrospective chart review without new interventions, patient consent was waived by the ethics committee.
Treatment Groups
Patients were categorized based on their actual prescribed regimens:
Amoxicillin + Vonoprazan (10-day course)
Amoxicillin + Vonoprazan (14-day course)
Amoxicillin + Tegoprazan (14-day course)
Amoxicillin + Esomeprazole (14-day course)
These groups were compared to assess differences in H. pylori eradication rates.
Study Characteristics No active intervention or real-time questionnaire collection was involved.
Complies with the real-world evidence (RWE) framework for retrospective studies.
Primary Outcome Eradication rate comparison between HDDT regimens (assessed via modified intention-to-treat analysis).
Secondary Outcomes Adverse event rates across different HDDT regimens.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- This study is a retrospective study, and all data have been collected in advance with no active intervention required.
- Keywords
- Helicobacter pylori, dual therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study is a retrospective study, and all data have been collected in advance with no active intervention required.Other
This study is a retrospective study, and all data have been collected in advance with no active intervention required.
| Study group | Role | What they receive |
|---|---|---|
| VA-10 day group | Not described Receives: Other: This study is a retrospective study, and all data have been collected in advance with no active intervention required. | |
| VA-14 day group | Not described Receives: Other: This study is a retrospective study, and all data have been collected in advance with no active intervention required. | |
| TA group | Not described Receives: Other: This study is a retrospective study, and all data have been collected in advance with no active intervention required. | |
| EA group | Not described Receives: Other: This study is a retrospective study, and all data have been collected in advance with no active intervention required. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
Comparison of Eradication Rates among Four Different High-Dose Dual Therapies for Helicobacter pylori
Measured: 4-6 weeks
Comparison of Eradication Rates Among Four Different High-Dose Dual Therapies for Helicobacter pylori
Measured: 4-6 weeks
Secondary outcomes (1)
Adverse Events and Compliance
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Jun 2025
- Primary completion1 Jul 2025
- Study completion20 Jul 2025
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 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liyueyue
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University
- Responsible party
- Sponsor-investigator, Liyueyue, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121205
- Sponsor's protocol ID
- KYLL-2025-07-009
- Other IDs
- KYLL-2025-07-009
- Acronym
- RETROHP
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wiklund AK, Santoni G, Yan J, Radkiewicz C, Xie S, Birgisson H, Ness-Jensen E, von Euler-Chelpin M, Kauppila JH, Lagergren J. Risk of Gastric Adenocarcinoma After Eradication of Helicobacter pylori. Gastroenterology. 2025 Aug;169(2):244-250.e1. doi: 10.1053/j.gastro.2025.01.239. Epub 2025 Feb 7.
PubMed 39924057Park JY, Georges D, Alberts CJ, Bray F, Clifford G, Baussano I. Global lifetime estimates of expected and preventable gastric cancers across 185 countries. Nat Med. 2025 Sep;31(9):3020-3027. doi: 10.1038/s41591-025-03793-6. Epub 2025 Jul 7.
PubMed 40624406
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of High-Dose Dual Therapies in First-Line Helicobacter Pylori Eradication: A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT07121205
- Acronym / sponsor ID
- RETROHP / KYLL-2025-07-009
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Keywords
- Helicobacter pylori, dual therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- LiyueyueUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 13 Aug 2025 (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.
Background:
High-dose dual therapy (HDDT) has emerged as a potential first-line treatment for Helicobacter pylori infection, but its efficacy and safety across different regimens and populations remain unclear. This study aimed to compare real-world outcomes of various HDDT protocols and identify factors influencing treatment failure.
Methods:
A multicenter retrospective analysis was conducted using data from 15 medical centers (January 2022-January 2025). Patients received one of four HDDT regimens: vonoprazan-amoxicillin for 10 days (VA-10) or 14 days (VA-14), esomeprazole-amoxicillin (EA), or tegoprazan-amoxicillin (TA). Primary outcomes included eradication rates (modified intention-to-treat analysis) and adverse events.
Detailed description
This study is a multicenter, retrospective, observational study utilizing medical records of outpatients who received standard high-dose dual therapy (HDDT) for Helicobacter pylori eradication between January 2022 and January 2025. The aim was to compare the efficacy and adverse event rates of different HDDT regimens.
Collected data included:
Baseline demographics (age, sex, etc.)
Medical/lifestyle history
Treatment regimens
Adverse events
Compliance
All data were anonymized at collection, and no additional patient contact or information collection was required. Since this study involved only retrospective chart review without new interventions, patient consent was waived by the ethics committee.
Treatment Groups
Patients were categorized based on their actual prescribed regimens:
Amoxicillin + Vonoprazan (10-day course)
Amoxicillin + Vonoprazan (14-day course)
Amoxicillin + Tegoprazan (14-day course)
Amoxicillin + Esomeprazole (14-day course)
These groups were compared to assess differences in H. pylori eradication rates.
Study Characteristics No active intervention or real-time questionnaire collection was involved.
Complies with the real-world evidence (RWE) framework for retrospective studies.
Primary Outcome Eradication rate comparison between HDDT regimens (assessed via modified intention-to-treat analysis).
Secondary Outcomes Adverse event rates across different HDDT regimens.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VA-10 day group | – | Other: This study is a retrospective study, and all data have been collected in advance with no active intervention required. |
| VA-14 day group | – | Other: This study is a retrospective study, and all data have been collected in advance with no active intervention required. |
| TA group | – | Other: This study is a retrospective study, and all data have been collected in advance with no active intervention required. |
| EA group | – | Other: This study is a retrospective study, and all data have been collected in advance with no active intervention required. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- (1) patients aged 18-70 years, regardless of gender; (2) absent history of receiving H. pylori eradication therapy; (3) diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.
Key inclusion criteria (1 listed)
- (1) patients aged 18-70 years, regardless of gender; (2) absent history of receiving H. pylori eradication therapy; (3) diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.
Key exclusion criteria (1 listed)
- (1) patients with incomplete medical records, including missing treatment details, absence of post-treatment follow-up test results, or failure to complete essential follow-up assessments; (2) patients who received treatment regimens that did not conform to the standardized HDDT protocol specified in this study.
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 |
|---|---|---|
| This study is a retrospective study, and all data have been collected in advance with no active intervention required.This study is a retrospective study, and all data have been collected in advance with no active intervention required. | Other | EA group, TA group, VA-10 day group, VA-14 day group |
Primary outcome
Eradication rate
Time frame: 4-6 weeks
Comparison of Eradication Rates among Four Different High-Dose Dual Therapies for Helicobacter pylori
Comparison of Eradication Rates Among Four Different High-Dose Dual Therapies for Helicobacter pylori
Time frame: 4-6 weeks
1 secondary outcome
Adverse Events and Compliance
Time frame: 4-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Background: PubMed 39924057Wiklund AK, Santoni G, Yan J, Radkiewicz C, Xie S, Birgisson H, Ness-Jensen E, von Euler-Chelpin M, Kauppila JH, Lagergren J. Risk of Gastric Adenocarcinoma After Eradication of Helicobacter pylori. Gastroenterology. 2025 Aug;169(2):244-250.e1. doi: 10.1053/j.gastro.2025.01.239. Epub 2025 Feb 7.
- Background: PubMed 40624406Park JY, Georges D, Alberts CJ, Bray F, Clifford G, Baussano I. Global lifetime estimates of expected and preventable gastric cancers across 185 countries. Nat Med. 2025 Sep;31(9):3020-3027. doi: 10.1038/s41591-025-03793-6. Epub 2025 Jul 7.
- 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. 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?
An observational study of HELICOBACTER PYLORI INFECTIONS, run by Liyueyue 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 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: finished, as of the sponsor's last update on 13 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 4-6 weeks). The study lists 2 primary outcomes in all. 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 NCT07121205, 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 13 Aug 2025.