Helicobacter Pylori InfectionReal-world_HpNCT05475431
Real-world Treatment of H. Pylori Eradication in Patients with Comorbidity
An observational study of Helicobacter Pylori Infection and Comorbidities and Coexisting Conditions, run by National Cheng-Kung University Hospital at 2 sites in Taiwan.
Trial summary
Most of the studies of H. pylori eradication were conducted in academic institutes and designed to enrolled patients who did not have comorbidities. However, patients in the real world may comorbid with diabetes, chronic obstructive pulmonary disease, cirrhosis, chronic kidney diseases, or others. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Helicobacter Pylori Infection, Comorbidities and Coexisting Conditions, Real-world Outcome
- What is being tested?
- The sequential therapy, The triple therapy and The hybrid therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 1,053 participants
- Where
- 2 sitesTaiwan
- Study dates
- 6 May 2020to 31 Dec 2023
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is conducted at the outpatient department of National Cheng Kung University Hospital in Tainan, Taiwan. Patients who are diagnosed with H. pylori infection and receive H. pylori eradication in the hospital are the candidates to be reviewed.
Who may be able to join
- Patients who are >= 20 years and received the therapy for H. pylori eradication from January 1, 2012 to December 31, 2019 are reviewed retrospectively. The regimens include 10- or 14-day sequential therapy, 7-, 10-, or 14-day triple therapy, 10- or 14-day hybrid therapy, 7- or 14-day concomitant therapy, 10- or 14-day bismuth-based quadruple therapy.
Who cannot join
- Patients are excluded if they ever received H. pylori eradication before.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Cheng Kung University Hospital
Tainan, Taiwan, 704302
Helicobacter pylori study group, National Cheng Kung University Hospital
Tainan, 70403
About this study
Official title: The Most Appropriate Prescription of the First-line, the Second-line, and the Third Treatment for H. Pylori Eradication Among Patients Who Are Comorbid Diabetes Mellitus, Chronic Obstructive Pulmonary Disease, or Chronic Kidney Disease
Most of the studies of H. pylori eradication were conducted in academic institutes and designed to enrolled patients who did not have comorbidities. However, patients in the real world may comorbid with diabetes, chronic obstructive pulmonary disease, cirrhosis, chronic kidney diseases, or others. We hypothesize that the eradication rate of H. pylori in patients with comorbidity is poor because they may be infected with antibiotics-resistant H. pylori strains or have poor medication adherence. Here, we design a study, which focus on the H. pylori eradication rates by the various regimens in the real world, especially for those with high Charlson scores. It is presumed that our data will be helpful with regard to treating such patients with H. pylori eradication in the clinical scenario.
Read the detailed description
There is a challenge for eradicating Helicobacter pylori (H. pylori) because the resistant strains of H. pylori are increasing. In order to overcome the challenge, the new regimens are developed, including 14-day triple therapy, 10-day sequential therapy, 10-day bismuth-based quadruple therapy, 10-day concomitant therapy, or 14-day hybrid therapy, which have 84%~99% of successful eradication rates. Additionally, there is a new challenge, i.e., worldwide population aging and increases in the proportion of patients with comorbidity. Most of the studies of H. pylori eradication were conducted in academic institutes and designed to enrolled patients who did not have comorbidities. However, patients in the real world may comorbid with diabetes, chronic obstructive pulmonary disease, cirrhosis, chronic kidney diseases, or others. Our previous study showed that the eradication rate of 10-day clarithromycin-based sequential therapy was 81% in diabetic patients, lower than 87% in non-diabetic patients in other study. Therefore, we hypothesize that the eradication rate of H. pylori in patients with comorbidity is poor because they may be infected with antibiotics-resistant H. pylori strains or have poor medication adherence. The former is because patients may use macrolides because of chronic obstructive pulmonary disease with airway infection, for example. The latter is because the regimen of H. pylori eradication is complex, either three or four varieties of pills and dosage intervals for administration. Moreover, the patients may have taken many other medications for their underline comorbidity. These medications may have drug-drug interaction with the H. pylori eradication regimen or make the medication adherence poor. Most of studies which were conducted in academic institutes, patients took the H. pylori eradication regimen under the study staffs' instruction and monitor; however, in the real world, their medication adherence for H. pylori eradication may be compromised. Here, we design a study, which focus on the H. pylori eradication rates by the various regimens in the real world, especially for those with high Charlson scores. It is presumed that our data will be helpful with regard to treating such patients with H. pylori eradication in the clinical scenario.
- Conditions
- Helicobacter Pylori Infection, Comorbidities and Coexisting Conditions, Real-world Outcome, Medication Adherence, Patient Compliance, Patient Dropouts
- Being tested
- The sequential therapy, The triple therapy, The hybrid therapy, The concomitant therapy, Bismuth-based quadruple therapy
- Keywords
- Helicobacter pylori, Comorbidity, Patient dropouts, Medication adherence
- Medical subject headings
- Medication Adherence, Patient Compliance, Patient Dropouts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The sequential therapyDrug
Proton pump inhibitors and amoxicillin for the first 5 or 7 days and sequent proton pump inhibitors, clarithromycin, and metronidazole for the next 5 or 7 days
The triple therapyDrug
Proton pump inhibitors, amoxicillin, and clarithromycin for 7, 10, or 14 days.
The hybrid therapyDrug
Proton pump inhibitors and amoxicillin starting from the 1st day and for a total of 10 or 14 days, and clarithromycin, and metronidazole starting from the 8th day and for a total of 7 days .
The concomitant therapyDrug
Proton pump inhibitors, amoxicillin, clarithromycin, and metronidazole for a total of 7 or 14 days
Bismuth-based quadruple therapyDrug
Proton pump inhibitors, bismuth, tetracycline, and metronidazole for a total of 10 or 14 days
| Study group | Role | What they receive |
|---|---|---|
| The Charlson scores >= 2 | Patients who are >= 20 years and diagnosed with H. pylori infection either by rapid urease test or by histology from January 1, 2012 to December 31, 2019 are reviewed retrospectively. Patients are excluded if they ever received H. pylori eradication before. Patient characteristics, including age, sex, and the parameters of the Charlson scores, are recorded and analyzed. Moreover, the tablet number and varieties of medications patients took for underlying diseases are also recorded. If the patients' Charlson scores >= 2, they are divided into the Charlson scores >= 2 group. Receives: Drug: The sequential therapy; Drug: The triple therapy; Drug: The hybrid therapy; Drug: The concomitant therapy; Drug: Bismuth-based quadruple therapy | |
| The Charlson scores < 2 | Patients who are >= 20 years and diagnosed with H. pylori infection either by rapid urease test or by histology from January 1, 2012 to December 31, 2019 are reviewed retrospectively. Patients are excluded if they ever received H. pylori eradication before. Patient characteristics, including age, sex, and the parameters of the Charlson scores, are recorded and analyzed. Moreover, the tablet number and varieties of medications patients took for underlying diseases are also recorded. If the patients' Charlson scores < 2, they are divided into the Charlson scores < 2 group. Receives: Drug: The sequential therapy; Drug: The triple therapy; Drug: The hybrid therapy; Drug: The concomitant therapy; Drug: Bismuth-based quadruple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The eradication rate by the intention-to-treat analysis
Successful H. pylori eradication is confirmed by the 13C-urea breath test, rapid urease test, or H. pylori stool antigen test. All the reviewed patients are analyzed for intention-to-treat of H. pylori eradication.
Measured: At least six weeks after the completion of H. pylori eradication
The eradication rate by the per-protocol analysis
Successful H. pylori eradication is confirmed by the 13C-urea breath test, rapid urease test, or H. pylori stool antigen test. Patients who do not complete the regimens or do not receive the confirmation of successful H. pylori eradication by the 13C-urea breath test, rapid urease test, or H. pylori stool antigen test are excluded from the per-protocol analysis.
Measured: At least six weeks after the completion of H. pylori eradication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start6 May 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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.
- More trials run by National Cheng-Kung 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475431
- Sponsor's protocol ID
- B-ER-109-072
- Acronym
- Real-world_Hp
- Status last verified
- Oct 2023
- First submitted
- 24 Jul 2022
- Last updated
- 7 Nov 2024
- 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 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Most Appropriate Prescription of the First-line, the Second-line, and the Third Treatment for H. Pylori Eradication Among Patients Who Are Comorbid Diabetes Mellitus, Chronic Obstructive Pulmonary Disease, or Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05475431
- Acronym / sponsor ID
- Real-world_Hp / B-ER-109-072
- Conditions
- Helicobacter Pylori Infection, Comorbidities and Coexisting Conditions, Real-world Outcome, Medication Adherence, Patient Compliance, Patient Dropouts
- Keywords
- Helicobacter pylori, Comorbidity, Patient dropouts, Medication adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,053 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- 6 May 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Jul 2022 (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.
Most of the studies of H. pylori eradication were conducted in academic institutes and designed to enrolled patients who did not have comorbidities. However, patients in the real world may comorbid with diabetes, chronic obstructive pulmonary disease, cirrhosis, chronic kidney diseases, or others. We hypothesize that the eradication rate of H. pylori in patients with comorbidity is poor because they may be infected with antibiotics-resistant H. pylori strains or have poor medication adherence. Here, we design a study, which focus on the H. pylori eradication rates by the various regimens in the real world, especially for those with high Charlson scores. It is presumed that our data will be helpful with regard to treating such patients with H. pylori eradication in the clinical scenario.
Detailed description
There is a challenge for eradicating Helicobacter pylori (H. pylori) because the resistant strains of H. pylori are increasing. In order to overcome the challenge, the new regimens are developed, including 14-day triple therapy, 10-day sequential therapy, 10-day bismuth-based quadruple therapy, 10-day concomitant therapy, or 14-day hybrid therapy, which have 84%~99% of successful eradication rates. Additionally, there is a new challenge, i.e., worldwide population aging and increases in the proportion of patients with comorbidity. Most of the studies of H. pylori eradication were conducted in academic institutes and designed to enrolled patients who did not have comorbidities. However, patients in the real world may comorbid with diabetes, chronic obstructive pulmonary disease, cirrhosis, chronic kidney diseases, or others. Our previous study showed that the eradication rate of 10-day clarithromycin-based sequential therapy was 81% in diabetic patients, lower than 87% in non-diabetic patients in other study. Therefore, we hypothesize that the eradication rate of H. pylori in patients with comorbidity is poor because they may be infected with antibiotics-resistant H. pylori strains or have poor medication adherence. The former is because patients may use macrolides because of chronic obstructive pulmonary disease with airway infection, for example. The latter is because the regimen of H. pylori eradication is complex, either three or four varieties of pills and dosage intervals for administration. Moreover, the patients may have taken many other medications for their underline comorbidity. These medications may have drug-drug interaction with the H. pylori eradication regimen or make the medication adherence poor. Most of studies which were conducted in academic institutes, patients took the H. pylori eradication regimen under the study staffs' instruction and monitor; however, in the real world, their medication adherence for H. pylori eradication may be compromised. Here, we design a study, which focus on the H. pylori eradication rates by the various regimens in the real world, especially for those with high Charlson scores. It is presumed that our data will be helpful with regard to treating such patients with H. pylori eradication in the clinical scenario.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Charlson scores >= 2 | – | Drug: The sequential therapy, Drug: The triple therapy, Drug: The hybrid therapy, Drug: The concomitant therapy, Drug: Bismuth-based quadruple therapyPatients who are >= 20 years and diagnosed with H. pylori infection either by rapid urease test or by histology from January 1, 2012 to December 31, 2019 are reviewed retrospectively. Patients are excluded if they ever received H. pylori eradication before. Patient characteristics, including age, sex, and the parameters of the Charlson scores, are recorded and analyzed. Moreover, the tablet number and varieties of medications patients took for underlying diseases are also recorded. If the patients' Charlson scores >= 2, they are divided into the Charlson scores >= 2 group. |
| The Charlson scores < 2 | – | Drug: The sequential therapy, Drug: The triple therapy, Drug: The hybrid therapy, Drug: The concomitant therapy, Drug: Bismuth-based quadruple therapyPatients who are >= 20 years and diagnosed with H. pylori infection either by rapid urease test or by histology from January 1, 2012 to December 31, 2019 are reviewed retrospectively. Patients are excluded if they ever received H. pylori eradication before. Patient characteristics, including age, sex, and the parameters of the Charlson scores, are recorded and analyzed. Moreover, the tablet number and varieties of medications patients took for underlying diseases are also recorded. If the patients' Charlson scores < 2, they are divided into the Charlson scores < 2 group. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is conducted at the outpatient department of National Cheng Kung University Hospital in Tainan, Taiwan. Patients who are diagnosed with H. pylori infection and receive H. pylori eradication in the hospital are the candidates to be reviewed.
Key inclusion criteria (1 listed)
- Patients who are >= 20 years and received the therapy for H. pylori eradication from January 1, 2012 to December 31, 2019 are reviewed retrospectively. The regimens include 10- or 14-day sequential therapy, 7-, 10-, or 14-day triple therapy, 10- or 14-day hybrid therapy, 7- or 14-day concomitant therapy, 10- or 14-day bismuth-based quadruple therapy.
Key exclusion criteria (1 listed)
- Patients are excluded if they ever received H. pylori eradication before.
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 |
|---|---|---|
| The sequential therapyProton pump inhibitors and amoxicillin for the first 5 or 7 days and sequent proton pump inhibitors, clarithromycin, and metronidazole for the next 5 or 7 days | Drug | The Charlson scores < 2, The Charlson scores >= 2 |
| The triple therapyProton pump inhibitors, amoxicillin, and clarithromycin for 7, 10, or 14 days. | Drug | The Charlson scores < 2, The Charlson scores >= 2 |
| The hybrid therapyProton pump inhibitors and amoxicillin starting from the 1st day and for a total of 10 or 14 days, and clarithromycin, and metronidazole starting from the 8th day and for a total of 7 days . | Drug | The Charlson scores < 2, The Charlson scores >= 2 |
| The concomitant therapyProton pump inhibitors, amoxicillin, clarithromycin, and metronidazole for a total of 7 or 14 days | Drug | The Charlson scores < 2, The Charlson scores >= 2 |
| Bismuth-based quadruple therapyProton pump inhibitors, bismuth, tetracycline, and metronidazole for a total of 10 or 14 days | Drug | The Charlson scores < 2, The Charlson scores >= 2 |
Primary outcome
The eradication rate by the intention-to-treat analysis
Time frame: At least six weeks after the completion of H. pylori eradication
Successful H. pylori eradication is confirmed by the 13C-urea breath test, rapid urease test, or H. pylori stool antigen test. All the reviewed patients are analyzed for intention-to-treat of H. pylori eradication.
The eradication rate by the per-protocol analysis
Time frame: At least six weeks after the completion of H. pylori eradication
Successful H. pylori eradication is confirmed by the 13C-urea breath test, rapid urease test, or H. pylori stool antigen test. Patients who do not complete the regimens or do not receive the confirmation of successful H. pylori eradication by the 13C-urea breath test, rapid urease test, or H. pylori stool antigen test are excluded from the per-protocol analysis.
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 7 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection and Comorbidities and Coexisting Conditions, run by National Cheng-Kung University Hospital at 2 sites in Taiwan.
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 1 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 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
The eradication rate by the intention-to-treat analysis (time frame: At least six weeks after the completion of H. pylori eradication). The study lists 2 primary outcomes in all. 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 7 Nov 2024.