H. Pylori InfectionNCT05453994
Bismuth for PCAB-based H. Pylori Eradication
An observational study of H. Pylori Infection, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
Tegoprazan is a new potassium-competitive acid blocker (PCAB) that has been clinically available since 2018 in South Korea. P-CAB is highly active drugs targeting H+, K+ -ATPase in the gastric acid secretion of parietal cells. The mechanism of action is different from that of PPIs. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- H. Pylori Infection
- What is being tested?
- H. pylori eradication
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2020to 31 Aug 2023
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: H. pylori-infected patients
Who may be able to join
- Gastroscopy can be performed
- H. pylori test and pathological analysis can be performed
Who cannot join
- Age < 20 or > 80 years
- Anemia (serum hemoglobin level < 10 g/dL)
- Severe systemic disease
- Advanced chronic liver disease
- Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
- History of H. pylori eradication
Show all 9Show fewer
- Drug allergy to antibiotics
- History of gastric surgery
- Recent history of upper gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Digestive Disease Center, Soonchunhyang University Hospital
Seoul, 04401
About this study
Official title: Efficacy of Bismuth Added to Potassium-competitive Acid Blocker-based Triple Regimen for First-line Helicobacter Pylori Eradication
Tegoprazan is a new potassium-competitive acid blocker (PCAB) that has been clinically available since 2018 in South Korea. P-CAB is highly active drugs targeting H+, K+ -ATPase in the gastric acid secretion of parietal cells. The mechanism of action is different from that of PPIs. Conventional PPIs require 3-5 days to achieve maximal and steady-state gastric acid inhibition, whereas P-CAB increases the intragastric pH to nearly 7 within four hours. In Japan, H. pylori eradication success rates has increased by therapies using P-CAB than those using proton pump inhibitors, owing to the stronger acid suppression capability of P-CAB.
Bismuth has long been used to treat peptic ulcer disease, dyspepsia, parasite infections, and infectious diarrhea. The antibacterial effects of bismuth include inhibition of protein and cell wall synthesis in H. pylori. The main role of bismuth is to increase the eradication rate by 30%-40% in resistant H. pylori strains.
Read the detailed description
The investigators aim to evaluate the success rate and adverse drug events of bismuth added to PCAB-based triple therapy as a first-line regimen for H. pylori infection.
- Conditions
- H. Pylori Infection
- Being tested
- H. pylori eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H. pylori eradicationDrug
PPIs-based Antimicrobial agents for H. pylori eradication
| Study group | Role | What they receive |
|---|---|---|
| Non-bismuth group | Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid for 14 days Receives: Drug: H. pylori eradication | |
| Bismuth group | Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days Receives: Drug: H. pylori eradication |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori infection status
Rate of successful H. pylori eradication
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 posted12 Jul 2022
- Study start1 Mar 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for H. 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Hyung Cho, Soonchunhyang University Hospital
- Investigators
- Jun-Hyung Cho, M.D., Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453994
- Sponsor's protocol ID
- SCH-HP-2022
- Status last verified
- Nov 2023
- First submitted
- 6 Jul 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho JH. Bismuth add-on improves the efficacy of 2-week tegoprazan-based triple therapy for first-line Helicobacter pylori eradication: a real-world evidence study. Expert Rev Anti Infect Ther. 2024 Sep;22(9):793-799. doi: 10.1080/14787210.2024.2329251. Epub 2024 Mar 13.
PubMed 38459869
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bismuth Added to Potassium-competitive Acid Blocker-based Triple Regimen for First-line Helicobacter Pylori Eradication
- ClinicalTrials.gov ID
- NCT05453994
- Acronym / sponsor ID
- SCH-HP-2022
- Conditions
- H. Pylori Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 12 Jul 2022 (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.
Tegoprazan is a new potassium-competitive acid blocker (PCAB) that has been clinically available since 2018 in South Korea. P-CAB is highly active drugs targeting H+, K+ -ATPase in the gastric acid secretion of parietal cells. The mechanism of action is different from that of PPIs. Conventional PPIs require 3-5 days to achieve maximal and steady-state gastric acid inhibition, whereas P-CAB increases the intragastric pH to nearly 7 within four hours. In Japan, H. pylori eradication success rates has increased by therapies using P-CAB than those using proton pump inhibitors, owing to the stronger acid suppression capability of P-CAB.
Bismuth has long been used to treat peptic ulcer disease, dyspepsia, parasite infections, and infectious diarrhea. The antibacterial effects of bismuth include inhibition of protein and cell wall synthesis in H. pylori. The main role of bismuth is to increase the eradication rate by 30%-40% in resistant H. pylori strains.
Detailed description
The investigators aim to evaluate the success rate and adverse drug events of bismuth added to PCAB-based triple therapy as a first-line regimen for H. pylori infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-bismuth group | – | Drug: H. pylori eradicationTegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid for 14 days |
| Bismuth group | – | Drug: H. pylori eradicationTegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- H. pylori-infected patients
Key inclusion criteria (2 listed)
- Gastroscopy can be performed
- H. pylori test and pathological analysis can be performed
Key exclusion criteria (9 listed)
- Age < 20 or > 80 years
- Anemia (serum hemoglobin level < 10 g/dL)
- Severe systemic disease
- Advanced chronic liver disease
- Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
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 |
|---|---|---|
| H. pylori eradicationPPIs-based Antimicrobial agents for H. pylori eradication | Drug | Bismuth group, Non-bismuth group |
Primary outcome
H. pylori infection status
Time frame: 6 weeks
Rate of successful H. pylori eradication
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 22 Nov 2023.
- Derived from this study: PubMed 38459869Cho JH. Bismuth add-on improves the efficacy of 2-week tegoprazan-based triple therapy for first-line Helicobacter pylori eradication: a real-world evidence study. Expert Rev Anti Infect Ther. 2024 Sep;22(9):793-799. doi: 10.1080/14787210.2024.2329251. Epub 2024 Mar 13.
- Individual participant dataSharing planned: No
Related trials for H. Pylori Infection
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
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Not yet recruitingPhase 2
Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Infection in United States Adolescents
Helicobacter Pylori Infection
Active, not recruiting
Efficacy and Safety of Second-Line Helicobacter Pylori Eradication
HELICOBACTER PYLORI INFECTIONS
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.
Jun-Hyung Cho, M.D. principal investigator
Soonchunhyang University Hospital
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 H. Pylori Infection, run by Soonchunhyang University Hospital at 1 site in South Korea.
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 2 inclusion and 9 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 22 Nov 2023. 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 South Korea. 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?
H. pylori infection status (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 NCT05453994, which also lists 1 linked publication.
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 22 Nov 2023.