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NCT Number: NCT05475431

Real-world Treatment of H. Pylori Eradication in 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. 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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Key information

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cheng Kung University Hospital, Tainan, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The sequential therapy

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

Drug

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

The hybrid therapy

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

Drug

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

Bismuth-based quadruple therapy

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Collaborators

  • Ministry of Health and Welfare, Taiwan

Registry information

Official study 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

Acronym: Real-world_Hp

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2022
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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