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Completed

NCT Number: NCT05173493

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

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Amoxicillin,Furazolidone

Drug

Amoxicillin-Furazolidone-containing quadruple group

Amoxicillin,Levofloxacin

Drug

Amoxicillin-Levofloxacin-containing quadruple group

Tetracycline,Furazolidone

Drug

Tetracycline-Furazolidone-containing quadruple group

Primary outcomes

  1. The most suitable re-eradication time

    Time frame: 6 months

    The most suitable re-eradication time（The unit is month） will be assessed by paired comparison method .

Secondary outcomes

  1. Eradication rates in three groups

    Time frame: 6months

    Both 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.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

  • Dezhou People's Hospital
  • Shengli Oilfield Hospital
  • Taian City Central Hospital
  • The Affiliated Hospital of Qingdao University
  • Weifang Medical University

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 30, 2021
Registry last updated
Feb 17, 2023

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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