Helicobacter Pylori InfectionNCT03884348
Tailored H. Pylori Eradication Based on Clarithromycin Resistance
An observational study of Helicobacter Pylori Infection and Antibiotic Resistant Strain, run by Kangdong Sacred Heart Hospital.
Trial summary
The investigators investigated the point mutations in the 23S rRNA genes of patients infected with clarithromycin-resistant H. pylori and compared the H. pylori eradication rates based on the identified clinically significant point mutations. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Helicobacter Pylori Infection, Antibiotic Resistant Strain
- What is being tested?
- proton pump inhibitor, amoxicillin, clarithromycin and proton pump inhibitor, amoxicillin, metronidazole
- How many people
- 431 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2018
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Helicobacter-pylori positive patients with gastritis, ulcer, adenoma
Who may be able to join
- Clinical diagnosis of Helicobacter pylori infection
Who cannot join
- H. pylori eradication therapy within 1 year,
- antibiotics within 4 weeks,
- surgery for gastric cancer
- malignant tumors other than gastric cancer
- end-stage renal disease
- liver cirrhosis,
- pregnancy
About this study
Official title: Helicobacter Pylori Eradication According to Sequencing-based 23S Ribosomal RNA Point Mutation Associated With Clarithromycin Resistance
The investigators investigated the point mutations in the 23S rRNA genes of patients infected with clarithromycin-resistant H. pylori and compared the H. pylori eradication rates based on the identified clinically significant point mutations.
Read the detailed description
Sequencing-based detection of point mutations identified four mutations that were considered clinically significant (A2142G, A2142C, A2143G, A2143C), while all the other mutations were considered clinically insignificant.
Participants who did not have point mutations related to clarithromycin resistance and/or had clinically insignificant point mutations were treated with PAC (proton pump inhibitor, amoxicillin, clarithromycin) for 7 days, while participants with clinically significant point mutations were treated with PAM (proton pump inhibitor, amoxicillin, metronidazole) for 7 days. H. pylori eradication rates were compared between the two groups.
- Being tested
- proton pump inhibitor, amoxicillin, clarithromycin, proton pump inhibitor, amoxicillin, metronidazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proton pump inhibitor, amoxicillin, clarithromycinDrug
non-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin
proton pump inhibitor, amoxicillin, metronidazoleDrug
clarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole
| Study group | Role | What they receive |
|---|---|---|
| PAM-treated clarithromycin-resistance group | Treatment with PPI twice a day, amoxicillin (1000 mg) twice a day, and metronidazole (500 mg) three times a day for 7 days in patients with clinically significant point mutations Receives: Drug: proton pump inhibitor, amoxicillin, metronidazole | |
| PAC-treated nonresistance group | Treatment with PPI twice a day, amoxicillin (1000 mg) twice a day, and clarithromycin (500 mg) twice a day for 7 day in patients with clinically insignificant point mutations Receives: Drug: proton pump inhibitor, amoxicillin, clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
Number of participant with successful Helicobacter pylori eradication
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Jan 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 431 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
- NCT03884348
- Sponsor's protocol ID
- Kangdong2017-03-005
- Status last verified
- Mar 2019
- First submitted
- 14 Mar 2019
- Last updated
- 21 Mar 2019
- 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 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Eradication According to Sequencing-based 23S Ribosomal RNA Point Mutation Associated With Clarithromycin Resistance
- ClinicalTrials.gov ID
- NCT03884348
- Acronym / sponsor ID
- Kangdong2017-03-005
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Kangdong Sacred Heart HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 21 Mar 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.
The investigators investigated the point mutations in the 23S rRNA genes of patients infected with clarithromycin-resistant H. pylori and compared the H. pylori eradication rates based on the identified clinically significant point mutations.
Detailed description
Sequencing-based detection of point mutations identified four mutations that were considered clinically significant (A2142G, A2142C, A2143G, A2143C), while all the other mutations were considered clinically insignificant.
Participants who did not have point mutations related to clarithromycin resistance and/or had clinically insignificant point mutations were treated with PAC (proton pump inhibitor, amoxicillin, clarithromycin) for 7 days, while participants with clinically significant point mutations were treated with PAM (proton pump inhibitor, amoxicillin, metronidazole) for 7 days. H. pylori eradication rates were compared between the two groups.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAM-treated clarithromycin-resistance group | – | Drug: proton pump inhibitor, amoxicillin, metronidazoleTreatment with PPI twice a day, amoxicillin (1000 mg) twice a day, and metronidazole (500 mg) three times a day for 7 days in patients with clinically significant point mutations |
| PAC-treated nonresistance group | – | Drug: proton pump inhibitor, amoxicillin, clarithromycinTreatment with PPI twice a day, amoxicillin (1000 mg) twice a day, and clarithromycin (500 mg) twice a day for 7 day in patients with clinically insignificant point mutations |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Helicobacter-pylori positive patients with gastritis, ulcer, adenoma
Key inclusion criteria (1 listed)
- Clinical diagnosis of Helicobacter pylori infection
Key exclusion criteria (7 listed)
- H. pylori eradication therapy within 1 year,
- antibiotics within 4 weeks,
- surgery for gastric cancer
- malignant tumors other than gastric cancer
- end-stage renal disease
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 |
|---|---|---|
| proton pump inhibitor, amoxicillin, clarithromycinnon-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin | Drug | PAC-treated nonresistance group |
| proton pump inhibitor, amoxicillin, metronidazoleclarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole | Drug | PAM-treated clarithromycin-resistance group |
Primary outcome
Helicobacter pylori eradication rate
Time frame: 2 year
Number of participant with successful Helicobacter 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 21 Mar 2019.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection and Antibiotic Resistant Strain, run by Kangdong Sacred Heart Hospital.
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: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Helicobacter pylori eradication rate (time frame: 2 year). 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 21 Mar 2019.