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

Completed

• Conditions: Helicobacter Pylori Infection; Comorbidities and Coexisting Conditions; Medication Adherence; Patient Compliance; Patient Dropouts; Real-world Outcome
• Interventions: Drug: The sequential therapy; Drug: The triple therapy; Drug: The hybrid therapy; Drug: The concomitant therapy; Drug: Bismuth-based quadruple therapy

• Registration Number: NCT05475431
• Lead Sponsor: National Cheng-Kung University Hospital

Brief 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. 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 Timeline

• Study Start: 2020-05-06
• Study First Submitted: 2022-07-24
• Study First Submitted QC: 2022-07-24
• Study First Posted: 2022-07-27
• Status Verified: 2023-10
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1053

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.

Exclusion Criteria

• Patients are excluded if they ever received H. pylori eradication before.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The Charlson scores >= 2	The sequential therapy	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 Charlson scores >= 2	The triple therapy	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 Charlson scores < 2	The sequential therapy	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 Charlson scores < 2	The concomitant therapy	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 Charlson scores >= 2	The hybrid therapy	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 Charlson scores >= 2	The concomitant therapy	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 Charlson scores < 2	The hybrid therapy	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 Charlson scores < 2	Bismuth-based quadruple therapy	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 Charlson scores >= 2	Bismuth-based quadruple therapy	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 Charlson scores < 2	The triple therapy	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.

Primary Outcome Measures

Name	Time	Method
The eradication rate by the intention-to-treat analysis	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	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.

Trial Locations

Locations (2)

Helicobacter pylori study group, National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan