Helicobacter Pylori InfectionNCT04462133
Optimal Tailored Treatment for H. Pylori Infection
A study testing Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR) in people with Helicobacter Pylori Infection and Antibiotic Resistant Infection, run by Incheon St.Mary's Hospital at 1 site in South Korea.
Trial summary
The efficacy of the current standard triple therapy is at an unacceptably low level. Resistance to antibiotics is suspected to be the major cause of the low efficacy of standard triple therapy. Point mutations in the 23S rRNA gene are known to be the primary mechanism of clarithromycin resistance against H pylori. Read more about this study
- Who is it for?
- Ages 19 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection, Antibiotic Resistant Infection
- What is being tested?
- Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2020to 1 Oct 2024
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- consecutive subjects who underwent upper gastrointestinal endoscopy and who had a confirmed diagnosis of H pylori infection
Who cannot join
- subjects younger than 18 years old
- subjects with a history of H pylori eradication
- subjects who had previous gastric surgery
- subjects who were pregnant or lactating
- subjects with serious concurrent illness
- subjects who were administered antibiotics, bismuth, or PPIs in the 8 weeks preceding the study
- subjects with a history of allergy to any one of the compounds in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Tailored Treatment for H. Pylori Infection According to the Presence of DPO-PCR Based Clarithromycin Resistance
The efficacy of the current standard triple therapy is at an unacceptably low level. Resistance to antibiotics is suspected to be the major cause of the low efficacy of standard triple therapy. Point mutations in the 23S rRNA gene are known to be the primary mechanism of clarithromycin resistance against H pylori. Recently, a point mutation detection kit using a dual-priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) assay was introduced and made commercially available. The primary goal of our study was to compare the eradication rates of empirical therapy and tailored therapy. Specifically we examined the eradication rates of 7-d, 14-d empirical therapy with 7-d, 14-d tailored therapy. Our secondary goal was to examine the adverse events of each treatment, cost effectiveness of each treatment methods, and accuracy of DPO-PCR for detecting H. pylori resistance.
Read the detailed description
Patients are randomly assigned to the empirical therapy group and tailored therapy group.
The empirical therapy group recieves triple therapy of 7 or 14 days. The tailored therapy group receives treatment based on their DPO-PCR results.
Patients who are sensitive to clarithromycin based on DPO-PCR receives triple therapy for 7 or 14 days. Patients who are resistant to clarithromycin based on DPO-PCR recieves bismuth quadruple therapy for 7 or 14 days.
- Being tested
- Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)Diagnostic test
Empirical H. pylori eradication treatment versus tailored therapy based on DPO-PCR results
| Study group | Role | What they receive |
|---|---|---|
| Empirical therapy for H. pylori infection | Active comparator | The empirical group receives triple therapy of 7 or 14 days for H. pylori eradication Receives: Diagnostic Test: Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR) |
| Tailored therapy for H. pylori infection | Experimental | The tailored therapy group receives eradication regimens based on their DPO-PCR results. Triple therapy of 7 or 14 days for clarithromycin sensitive patients based on DPO-PCR and bismuth quadruple therapy of 7 or 14 days for clarithromycin resistant patients based on DPO-PCR. Receives: Diagnostic Test: Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication success
- pylori eradication success based on urea breath test
Measured: 8-12 weeks after eradication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Why it stopped: The study design was changed.
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
- Model description
- Empirical treatment versus tailored therapy
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incheon St.Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Sung Kim, Incheon St.Mary's Hospital
- Investigators
- Byung-Wook Kim, MD, PhD, Principal investigator, Incheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462133
- Sponsor's protocol ID
- XC20ENDT0022
- Status last verified
- May 2024
- First submitted
- 28 Jun 2020
- Last updated
- 16 May 2024
- Results posted
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Tailored Treatment for H. Pylori Infection According to the Presence of DPO-PCR Based Clarithromycin Resistance
- ClinicalTrials.gov ID
- NCT04462133
- Acronym / sponsor ID
- XC20ENDT0022
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study design was changed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Incheon St.Mary's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 8 Jul 2020 (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 efficacy of the current standard triple therapy is at an unacceptably low level. Resistance to antibiotics is suspected to be the major cause of the low efficacy of standard triple therapy. Point mutations in the 23S rRNA gene are known to be the primary mechanism of clarithromycin resistance against H pylori. Recently, a point mutation detection kit using a dual-priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) assay was introduced and made commercially available. The primary goal of our study was to compare the eradication rates of empirical therapy and tailored therapy. Specifically we examined the eradication rates of 7-d, 14-d empirical therapy with 7-d, 14-d tailored therapy. Our secondary goal was to examine the adverse events of each treatment, cost effectiveness of each treatment methods, and accuracy of DPO-PCR for detecting H. pylori resistance.
Detailed description
Patients are randomly assigned to the empirical therapy group and tailored therapy group.
The empirical therapy group recieves triple therapy of 7 or 14 days. The tailored therapy group receives treatment based on their DPO-PCR results.
Patients who are sensitive to clarithromycin based on DPO-PCR receives triple therapy for 7 or 14 days. Patients who are resistant to clarithromycin based on DPO-PCR recieves bismuth quadruple therapy for 7 or 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Empirical treatment versus tailored therapy
| Arm | Type | Receives |
|---|---|---|
| Empirical therapy for H. pylori infection | Active comparator | Diagnostic Test: Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)The empirical group receives triple therapy of 7 or 14 days for H. pylori eradication |
| Tailored therapy for H. pylori infection | Experimental | Diagnostic Test: Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)The tailored therapy group receives eradication regimens based on their DPO-PCR results. Triple therapy of 7 or 14 days for clarithromycin sensitive patients based on DPO-PCR and bismuth quadruple therapy of 7 or 14 days for clarithromycin resistant patients based on DPO-PCR. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- consecutive subjects who underwent upper gastrointestinal endoscopy and who had a confirmed diagnosis of H pylori infection
Key exclusion criteria (7 listed)
- subjects younger than 18 years old
- subjects with a history of H pylori eradication
- subjects who had previous gastric surgery
- subjects who were pregnant or lactating
- subjects with serious concurrent illness
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 |
|---|---|---|
| Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)Empirical H. pylori eradication treatment versus tailored therapy based on DPO-PCR results | Diagnostic test | Empirical therapy for H. pylori infection, Tailored therapy for H. pylori infection |
Primary outcome
Eradication success
Time frame: 8-12 weeks after eradication
H. pylori eradication success based on urea breath test
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- 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.
Byung-Wook Kim, MD, PhD principal investigator
Incheon St.Mary's 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 Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR) in people with Helicobacter Pylori Infection and Antibiotic Resistant Infection, run by Incheon St.Mary's 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 1 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: withdrawn, as of the sponsor's last update on 16 May 2024. 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 was withdrawn before enrolling participants, so there are no results.
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 success (time frame: 8-12 weeks after eradication). 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 16 May 2024.