Helicobacter Pylori 23S rRNA Clarithromycin Resistance MutationNCT04006340
Empirical vs Tailored Therapy for H. Pylori Infection
A study testing triple therapy, quadruple therapy and dual-priming oligonucleotide-based multiplex (DPO)-PCR test in people with Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation and Helicobacter Pylori Infection, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
We aimed to compare the efficacy of genotypic resistance-guided tailored therapy vs empirical therapy for eradication of Helicobacter pylori (H. pylori) infection in randomized controlled trials. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation, Helicobacter Pylori Infection
- What is being tested?
- triple therapy, quadruple therapy and dual-priming oligonucleotide-based multiplex (DPO)-PCR test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jan 2019to 31 Aug 2019
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with H. pylori who had undergone endoscopic resection for gastric neoplasm
- Patients with H. pylori who had diagnosed at peptic ulcer disease, MALT lymphoma
Who cannot join
- history of gastrectomy
- patients aged younger than 20 years or older than 80 years
- history of H. pylori eradication therapies or other antibiotics therapy within a month
- previous allergic reaction to the study drugs (amoxicillin, clarithromycin, metronidazole, tetracycline, and esomeprazole)
- contraindication to treatment drugs
- pregnant or lactating women
- severe concurrent illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Empirical and Genotypic Resistance Guided Tailored Therapy for Helicobacter Pylori Infection
We aimed to compare the efficacy of genotypic resistance-guided tailored therapy vs empirical therapy for eradication of Helicobacter pylori (H. pylori) infection in randomized controlled trials.
Read the detailed description
Empirical therapy is conventional triple therapy (proton pump inhibitor (PPI) standard dose, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days). Genotypic resistance-guided tailored therapy is the method which is chosen by DPO-PCR test. While the patients who have positive result of clarithromycin resistance receive the quadruple therapy(PPI standard dose, bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days), clarithromycin susceptible patients receive the triple therapy.
- pylori is difficult to cultivate, cultivation of H. pylori and minimum inhibitory concentration test as a resistance test method are very difficult and take a long time. Recently, tailored treatment based on clarithromycin susceptibility has been proposed by dual-priming oligonucleotide-based multiplex (DPO)-PCR test. This is a method to confirm the mutation of A2142G and A2143G by PCR, which are known to be highly related to the resistance of clarithromycin 23S rRNA point mutation. This test is performed only by gastric biopsy. The examination time is also short as several hours, and sensitivity and specificity are about 80-85%.
Antibiotic resistance of H. pylori, especially clarithromycin resistance, is a cause of major failure of its eradication, and Korea 's clarithromycin resistance rate is reported to be about 37%. The eradication rate of standard triple therapy reported in Korea is also unsatisfactory as antibiotic resistance rate of H. pylori increases. The ideal eradication rate for H. pylori is approximately 90%, but in the meta-analysis of the recently reported primary eradication, the overall eradication rate was 74.6% in the intention to treat analysis.
- Conditions
- Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation, Helicobacter Pylori Infection
- Being tested
- triple therapy, quadruple therapy, dual-priming oligonucleotide-based multiplex (DPO)-PCR test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triple therapyCombination product
esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg twice a day for 10 days
quadruple therapyCombination product
esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days
dual-priming oligonucleotide-based multiplex (DPO)-PCR testDiagnostic test
Resistance of clarithromycin 23S rRNA point mutation
| Study group | Role | What they receive |
|---|---|---|
| Empirical group | Placebo comparator | Patients receive conventional triple therapy containing esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days Receives: Combination Product: triple therapy |
| Genotypic resistance-guided tailored group | Active comparator | Patients receive triple or quadruple therapy by resistance-associated mutations in 23S ribosomal RNA which are identified by polymerase chain reaction (PCR).
Triple therapy contains esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days and quadruple therapy contains esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days. Receives: Combination Product: triple therapy; Combination Product: quadruple therapy; Diagnostic Test: dual-priming oligonucleotide-based multiplex (DPO)-PCR test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
Eradication rate of H. pylori infection
Measured: 13C-UBT at least 4 weeks after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start4 Jan 2019
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
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 Helicobacter Pylori 23S rRNA Clarithromycin Resistance MutationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Jeong Cho, Seoul National University Hospital
- Investigators
- Soo-Jeong Cho, M.D., ph.D., Principal investigator, Department of Internal Medicine and Liver Research Institute,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006340
- Sponsor's protocol ID
- 1811-029-983
- Status last verified
- Jul 2019
- First submitted
- 28 Jun 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim JL, Cho SJ, Chung SJ, Lee A, Choi J, Chung H, Kim SG. Empiric Versus Clarithromycin Resistance-Guided Therapy for Helicobacter pylori Based on Polymerase Chain Reaction Results in Patients With Gastric Neoplasms or Gastric Mucosa-Associated Lymphoid Tissue Lymphoma: A Randomized Controlled Trial. Clin Transl Gastroenterol. 2020 Sep;11(9):e00194. doi: 10.14309/ctg.0000000000000194.
PubMed 33094958
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Empirical and Genotypic Resistance Guided Tailored Therapy for Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT04006340
- Acronym / sponsor ID
- 1811-029-983
- Conditions
- Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation, Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 5 Jul 2019 (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.
We aimed to compare the efficacy of genotypic resistance-guided tailored therapy vs empirical therapy for eradication of Helicobacter pylori (H. pylori) infection in randomized controlled trials.
Detailed description
Empirical therapy is conventional triple therapy (proton pump inhibitor (PPI) standard dose, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days). Genotypic resistance-guided tailored therapy is the method which is chosen by DPO-PCR test. While the patients who have positive result of clarithromycin resistance receive the quadruple therapy(PPI standard dose, bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days), clarithromycin susceptible patients receive the triple therapy.
- pylori is difficult to cultivate, cultivation of H. pylori and minimum inhibitory concentration test as a resistance test method are very difficult and take a long time. Recently, tailored treatment based on clarithromycin susceptibility has been proposed by dual-priming oligonucleotide-based multiplex (DPO)-PCR test. This is a method to confirm the mutation of A2142G and A2143G by PCR, which are known to be highly related to the resistance of clarithromycin 23S rRNA point mutation. This test is performed only by gastric biopsy. The examination time is also short as several hours, and sensitivity and specificity are about 80-85%.
Antibiotic resistance of H. pylori, especially clarithromycin resistance, is a cause of major failure of its eradication, and Korea 's clarithromycin resistance rate is reported to be about 37%. The eradication rate of standard triple therapy reported in Korea is also unsatisfactory as antibiotic resistance rate of H. pylori increases. The ideal eradication rate for H. pylori is approximately 90%, but in the meta-analysis of the recently reported primary eradication, the overall eradication rate was 74.6% in the intention to treat analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empirical group | Placebo comparator | Combination Product: triple therapyPatients receive conventional triple therapy containing esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days |
| Genotypic resistance-guided tailored group | Active comparator | Combination Product: triple therapy, Combination Product: quadruple therapy, Diagnostic Test: dual-priming oligonucleotide-based multiplex (DPO)-PCR testPatients receive triple or quadruple therapy by resistance-associated mutations in 23S ribosomal RNA which are identified by polymerase chain reaction (PCR). Triple therapy contains esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days and quadruple therapy contains esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with H. pylori who had undergone endoscopic resection for gastric neoplasm
- Patients with H. pylori who had diagnosed at peptic ulcer disease, MALT lymphoma
Key exclusion criteria (7 listed)
- history of gastrectomy
- patients aged younger than 20 years or older than 80 years
- history of H. pylori eradication therapies or other antibiotics therapy within a month
- previous allergic reaction to the study drugs (amoxicillin, clarithromycin, metronidazole, tetracycline, and esomeprazole)
- contraindication to treatment drugs
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 |
|---|---|---|
| triple therapyesomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg twice a day for 10 days | Combination product | Empirical group, Genotypic resistance-guided tailored group |
| quadruple therapyesomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days | Combination product | Genotypic resistance-guided tailored group |
| dual-priming oligonucleotide-based multiplex (DPO)-PCR testResistance of clarithromycin 23S rRNA point mutation | Diagnostic test | Genotypic resistance-guided tailored group |
Primary outcome
Eradication rate
Time frame: 13C-UBT at least 4 weeks after completion of treatment
Eradication rate of H. pylori infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 33094958Kim JL, Cho SJ, Chung SJ, Lee A, Choi J, Chung H, Kim SG. Empiric Versus Clarithromycin Resistance-Guided Therapy for Helicobacter pylori Based on Polymerase Chain Reaction Results in Patients With Gastric Neoplasms or Gastric Mucosa-Associated Lymphoid Tissue Lymphoma: A Randomized Controlled Trial. Clin Transl Gastroenterol. 2020 Sep;11(9):e00194. doi: 10.14309/ctg.0000000000000194.
Related trials for Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingObservational study
Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea
Helicobacter Pylori Infection, Helicobacter Pylori Associated Gastrointestinal Disease
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.
Soo-Jeong Cho, M.D., ph.D. principal investigator
Department of Internal Medicine and Liver Research Institute,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triple therapy, quadruple therapy and dual-priming oligonucleotide-based multiplex (DPO)-PCR test in people with Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation and Helicobacter Pylori Infection, run by Seoul National 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 7 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 5 Jul 2019. 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. Some participants in this study may receive a placebo. 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: 13C-UBT at least 4 weeks after completion of treatment). 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 NCT04006340, 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 5 Jul 2019.