Real-world Treatment of H. Pylori Eradication in Patients with Comorbidity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1053 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-06

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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

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Helicobacter Pylori Infection Comorbidities and Coexisting Conditions Real-world Outcome Medication Adherence Patient Compliance Patient Dropouts

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

The sequential therapy

Intervention Type DRUG

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 therapy

Intervention Type DRUG

Proton pump inhibitors, amoxicillin, and clarithromycin for 7, 10, or 14 days.

The hybrid therapy

Intervention Type DRUG

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 therapy

Intervention Type DRUG

Proton pump inhibitors, amoxicillin, clarithromycin, and metronidazole for a total of 7 or 14 days

Bismuth-based quadruple therapy

Intervention Type DRUG

Proton pump inhibitors, bismuth, tetracycline, and metronidazole for a total of 10 or 14 days

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.

The sequential therapy

Intervention Type DRUG

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 therapy

Intervention Type DRUG

Proton pump inhibitors, amoxicillin, and clarithromycin for 7, 10, or 14 days.

The hybrid therapy

Intervention Type DRUG

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 therapy

Intervention Type DRUG

Proton pump inhibitors, amoxicillin, clarithromycin, and metronidazole for a total of 7 or 14 days

Bismuth-based quadruple therapy

Intervention Type DRUG

Proton pump inhibitors, bismuth, tetracycline, and metronidazole for a total of 10 or 14 days

Interventions

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The sequential therapy

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

Intervention Type DRUG

The triple therapy

Proton pump inhibitors, amoxicillin, and clarithromycin for 7, 10, or 14 days.

Intervention Type DRUG

The hybrid therapy

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 .

Intervention Type DRUG

The concomitant therapy

Proton pump inhibitors, amoxicillin, clarithromycin, and metronidazole for a total of 7 or 14 days

Intervention Type DRUG

Bismuth-based quadruple therapy

Proton pump inhibitors, bismuth, tetracycline, and metronidazole for a total of 10 or 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.