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Completed

NCT Number: NCT04810793

The Study on 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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 257000, 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 in patients with Hp eradication failure.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients, aged between 18 and 70 years old, with positive H. pylori infection that was eradicated by previous therapies but failed are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion criteria

  • Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Treatment and study plan

Amoxicillin , Levofloxacin and Esomeprazole

Drug

Esomeprazole-Bismuth-Amoxicillin-Levofloxacin-containing quadruple regimens

Amoxicillin , Furazolidone and Esomeprazole

Drug

Esomeprazole-Bismuth-Amoxicillin-Furazolidone-containing quadruple regimens

Tetracycline , Furazolidone and Esomeprazole

Drug

Esomeprazole-Bismuth-Tetracycline-Furazolidone-containing quadruple regimens

Amoxicillin,Levofloxacin and Vonoprazan fumarate

Drug

Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group

Amoxicillin,Furazolidone and Vonoprazan fumarate

Drug

Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group

Tetracycline,Furazolidone and Vonoprazan fumarate

Drug

Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group

Primary outcomes

  1. The most suitable re-eradication time

    Time frame: 1year

    The most suitable re-eradication time will be assessed by paired comparison method .

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
2020
Primary completion
2022
Study completion
2022
First posted
Mar 23, 2021
Registry last updated
Oct 27, 2022

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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