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A Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure

A Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05493644
Enrollment
660
Registered
2022-08-09
Start date
2022-09-01
Completion date
2023-12-31
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Brief summary

The patients who accepted the quadruple eradication program of the helicobacter pylori but failed to eradicate helicobacter pylori will be assessed the most suitable re-eradication time of helicobacter pylori.

Detailed description

Helicobacter pylori (HP) infection is a common global infectious disease, which is an important cause of chronic gastritis, peptic ulcer and gastric cancer. At present, due to the non-standard Helicobacter pylori eradication program in clinical work, poor patient compliance and other reasons, the phenomenon of HP eradication treatment failure is more and more common. However, there is still no conclusion on the most appropriate time for remedial treatment inpatients with Hp eradication failure.

Interventions

Remedial therapy was performed within 3 months

Remedial therapy was performed within 3 to 6 months

Remedial therapy was performed within 6 to 12 months

Remedial therapy was performed after 12 months

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged 18-70 with H. pylori infection. * Patients with previous Helicobacter pylori eradication.

Exclusion criteria

* Patients treated with H2-receptor antagonist, PPI, bismuth and antibioticsin the previous 4 weeks. * Patients with gastrectomy, acute GI bleeding and advanced gastric cancer. * Patients with known or suspected allergy to study medications. * Currently pregnant or lactating. * Inability to provide informed consent and other situations that couldinterfere with the examination or therapeutic protocol.

Design outcomes

Primary

MeasureTime frameDescription
The most suitable re-eradication time12 monthsThe most suitable re-eradication time#The unit is month# will be assessed by paired comparison method .

Secondary

MeasureTime frameDescription
Eradication rates in three groups12 monthsBoth intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in three groups

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026