Helicobacter Pylori InfectionNCT03431688
Tailored Therapy for Clarithromycin-Resistant H. Pylori
A study testing PAM and PBMT in people with Helicobacter Pylori Infection, run by Kangdong Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Clarithromycin-resistant H. pylori is the main cause of H. pylori eradication failure. Tailored therapy on the basis of detection of a clarithromycin resistance mutation by PCR has been studied recently, however, there have been few studies comparing treatment regimen in patient with clarithromycin-resistant H. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- PAM and PBMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 782 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2018to 30 Dec 2020
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- peptic ulcer disease
- H. pylori gastritis
- low grade MALT lymphoma
Who cannot join
- history of gastric cancer surgery
- severe comorbidity (ESRD, LC)
- hypersensitivity to drug
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Comparison of Metronidazole-based Triple and Bismuth-based Quadruple Therapy for Clarithromycin Resistant-Helicobacter Pylori Infection: Randomized Controlled Trial
Clarithromycin-resistant H. pylori is the main cause of H. pylori eradication failure. Tailored therapy on the basis of detection of a clarithromycin resistance mutation by PCR has been studied recently, however, there have been few studies comparing treatment regimen in patient with clarithromycin-resistant H. pylori. We used sequencing-based clarithromycin resistance mutation and aimed to compare PAM (proton pump inhibitor, amoxicilline, metronidazole) regimen and PBMT (proton pump inhibitor, bismuth, metronidazole, tetracyclin) regimen in patient with clarithromycin-resistant H. pylori.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- PAM, PBMT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAMDrug
treatment with PPI, metonidazole, amoxicillin
PBMTDrug
treatment with PPI, metonidazole, bismuth, tetracyclin
| Study group | Role | What they receive |
|---|---|---|
| PAM | Active comparator | treatment with PPI, metonidazole, amoxicillin Receives: Drug: PAM |
| PBMT | Active comparator | treatment with PPI, metonidazole, bismuth, tetracyclin Receives: Drug: PBMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate
- pylori eradication rate
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Oct 2018
- Primary completion30 Oct 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 782 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangdong Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shin, Woon Geon, Kangdong Sacred Heart Hospital
- Investigators
- Woon Geon Shin, Principal investigator, Kangdong Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431688
- Sponsor's protocol ID
- KangdongSHH
- Status last verified
- Apr 2022
- First submitted
- 31 Jan 2018
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Comparison of Metronidazole-based Triple and Bismuth-based Quadruple Therapy for Clarithromycin Resistant-Helicobacter Pylori Infection: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03431688
- Acronym / sponsor ID
- KangdongSHH
- Conditions
- Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 782 participants (actual)
- Lead sponsor
- Kangdong Sacred Heart HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 13 Feb 2018 (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.
Clarithromycin-resistant H. pylori is the main cause of H. pylori eradication failure. Tailored therapy on the basis of detection of a clarithromycin resistance mutation by PCR has been studied recently, however, there have been few studies comparing treatment regimen in patient with clarithromycin-resistant H. pylori. We used sequencing-based clarithromycin resistance mutation and aimed to compare PAM (proton pump inhibitor, amoxicilline, metronidazole) regimen and PBMT (proton pump inhibitor, bismuth, metronidazole, tetracyclin) regimen in patient with clarithromycin-resistant H. pylori.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAM | Active comparator | Drug: PAMtreatment with PPI, metonidazole, amoxicillin |
| PBMT | Active comparator | Drug: PBMTtreatment with PPI, metonidazole, bismuth, tetracyclin |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- peptic ulcer disease
- H. pylori gastritis
- low grade MALT lymphoma
Key exclusion criteria (4 listed)
- history of gastric cancer surgery
- severe comorbidity (ESRD, LC)
- hypersensitivity to drug
- pregnancy
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 |
|---|---|---|
| PAMtreatment with PPI, metonidazole, amoxicillin | Drug | PAM |
| PBMTtreatment with PPI, metonidazole, bismuth, tetracyclin | Drug | PBMT |
Primary outcome
H. pylori eradication rate
Time frame: 14 days
H. pylori eradication rate
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 Sep 2025.
- 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.
Woon Geon Shin principal investigator
Kangdong Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAM and PBMT in people with Helicobacter Pylori Infection, run by Kangdong Sacred Heart 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 3 inclusion and 4 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 Sep 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 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 eradication rate (time frame: 14 days). 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 22 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.