H. Pylori InfectionNCT05002595
H. Pylori Treatment Between Modified Quadruple Regimen and Tailored Therapy
An observational study of H. Pylori Infection, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
The rate of H. pylori resistance to antimicrobial agents including clarithromycin (CAM) has increased worldwide. Eradication failure using triple therapy is strongly associated with CAM-resistant H. pylori. The tailored therapy is defined as a targeted H. 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
- 270 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2018to 31 Dec 2021
- 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
- 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: Comparison of Helicobacter Pylori Treatment Between Modified Quadruple Therapy and Tailored Eradication Based on the Presence of Clarithromycin Resistance
The rate of H. pylori resistance to antimicrobial agents including clarithromycin (CAM) has increased worldwide. Eradication failure using triple therapy is strongly associated with CAM-resistant H. pylori. The tailored therapy is defined as a targeted H. pylori eradication which emphasizes on predicting individual drug responses before treatment.
Dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection and identify CAM resistance. The use of DPO-PCR has increased the tailored H. pylori eradication rate in Korea. If DPO-PCR testing is not available, a 14-day modified bismuth-containing quadruple regimen is recommended as a first-line H. pylori eradication. However, there is no comparison study between modified quadruple therapy and tailored eradication based on the presence of CAM resistance using DPO-PCR.
Read the detailed description
The investigators aim to evaluate the success rate, adverse drug events, and cost-effectiveness of modified quadruple therapy, compared with tailored eradication based on the presence of CAM resistance.
- 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
Antimicrobial agents for H. pylori eradication
| Study group | Role | What they receive |
|---|---|---|
| Modified quadruple therapy | pantoprazole 40mg bid, amoxicillin 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 14 days Receives: Drug: H. pylori eradication | |
| Tailored eradication | pantoprazole 40mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid or pantoprazole 40mg bid, tetracycline 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 7 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 Aug 2021
- Study start1 Jan 2018
- Primary completion31 Aug 2021
- Study completion31 Dec 2021
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
- 270 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
- NCT05002595
- Sponsor's protocol ID
- SCH-HP-2021
- Status last verified
- Feb 2022
- First submitted
- 4 Aug 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho JH, Jin SY, Park S. Comparison of tailored Helicobacter pylori eradication versus modified bismuth quadruple therapy in Korea: a randomized controlled trial. Expert Rev Anti Infect Ther. 2022 Jun;20(6):923-929. doi: 10.1080/14787210.2022.2017280. Epub 2021 Dec 20.
PubMed 34883037
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Helicobacter Pylori Treatment Between Modified Quadruple Therapy and Tailored Eradication Based on the Presence of Clarithromycin Resistance
- ClinicalTrials.gov ID
- NCT05002595
- Acronym / sponsor ID
- SCH-HP-2021
- Conditions
- H. Pylori Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 Aug 2021 (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 rate of H. pylori resistance to antimicrobial agents including clarithromycin (CAM) has increased worldwide. Eradication failure using triple therapy is strongly associated with CAM-resistant H. pylori. The tailored therapy is defined as a targeted H. pylori eradication which emphasizes on predicting individual drug responses before treatment.
Dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection and identify CAM resistance. The use of DPO-PCR has increased the tailored H. pylori eradication rate in Korea. If DPO-PCR testing is not available, a 14-day modified bismuth-containing quadruple regimen is recommended as a first-line H. pylori eradication. However, there is no comparison study between modified quadruple therapy and tailored eradication based on the presence of CAM resistance using DPO-PCR.
Detailed description
The investigators aim to evaluate the success rate, adverse drug events, and cost-effectiveness of modified quadruple therapy, compared with tailored eradication based on the presence of CAM resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified quadruple therapy | – | Drug: H. pylori eradicationpantoprazole 40mg bid, amoxicillin 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 14 days |
| Tailored eradication | – | Drug: H. pylori eradicationpantoprazole 40mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid or pantoprazole 40mg bid, tetracycline 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 7 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 (8 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 eradicationAntimicrobial agents for H. pylori eradication | Drug | Modified quadruple therapy, Tailored eradication |
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 24 Feb 2022.
- Derived from this study: PubMed 34883037Cho JH, Jin SY, Park S. Comparison of tailored Helicobacter pylori eradication versus modified bismuth quadruple therapy in Korea: a randomized controlled trial. Expert Rev Anti Infect Ther. 2022 Jun;20(6):923-929. doi: 10.1080/14787210.2022.2017280. Epub 2021 Dec 20.
- 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.
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 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: finished, as of the sponsor's last update on 24 Feb 2022. 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 NCT05002595, 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 24 Feb 2022.