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

NCT05475431 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1053

Last updated 2024-11-07

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

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

DRUG

The triple therapy

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

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 .

DRUG

The concomitant therapy

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

DRUG

Bismuth-based quadruple therapy

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

Sponsors & Collaborators

  • Ministry of Health and Welfare, Taiwan

    collaborator OTHER_GOV

  • National Cheng-Kung University Hospital

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-06
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05475431 on ClinicalTrials.gov