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CompletedNCT04810793Updated Oct 27, 2022

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

An observational study in Helicobacter Pylori, sponsored by Shandong University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-27.

Sponsored by Shandong University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
820
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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 in patients with Hp eradication failure.

02

Conditions studied

  • Helicobacter Pylori

Keywords

  • Re-eradication time
  • Remedial treatment
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In context

Lead sponsor

Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The patients in Shandong province,aged between 18 and 70 years old, with positive H. pylori infection that was eradicated by previous therapies but failed are included.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
820 participants (actual)
Target follow-up
2 Months
Patient registry
Yes

Groups and cohorts

  • Amoxicillin-Levofloxacin-Esomeprazole-containing quadruple group

    Patients in amoxicillin-levofloxacin-esomeprazole-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd for 14d.

    Drug: Amoxicillin , Levofloxacin and Esomeprazole

  • Amoxicillin-Furazolidone-Esomeprazole-containing quadruple group

    Patients in amoxicillin-furazolidone-esomeprazole-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.

    Drug: Amoxicillin , Furazolidone and Esomeprazole

  • Tetracycline-Furazolidone-Esomeprazole-containing quadruple group

    Patients in tetracycline-furazolidone-esomeprazole-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid, tetracycline 500mg po qid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.

    Drug: Tetracycline , Furazolidone and Esomeprazole

  • Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group

    Patients in amoxicillin-levofloxacin-vonoprazan fumarate-containing quadruple group will receive vonoprazan fumarate 20mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd for 14d.

    Drug: Amoxicillin,Levofloxacin and Vonoprazan fumarate

  • Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group

    Patients in amoxicillin-furazolidone-vonoprazan fumarate-containing quadruple group will receive vonoprazan fumarate 20mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.

    Drug: Amoxicillin,Furazolidone and Vonoprazan fumarate

  • Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group

    Patients in tetracycline-furazolidone-vonoprazan fumarate-containing quadruple group will receive vonoprazan fumarate 20mg po bid, tetracycline 500mg po qid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.

    Drug: Tetracycline,Furazolidone and Vonoprazan fumarate

Interventions

  • DrugAmoxicillin , Levofloxacin and Esomeprazole

    Esomeprazole-Bismuth-Amoxicillin-Levofloxacin-containing quadruple regimens

  • DrugAmoxicillin , Furazolidone and Esomeprazole

    Esomeprazole-Bismuth-Amoxicillin-Furazolidone-containing quadruple regimens

  • DrugTetracycline , Furazolidone and Esomeprazole

    Esomeprazole-Bismuth-Tetracycline-Furazolidone-containing quadruple regimens

  • DrugAmoxicillin,Levofloxacin and Vonoprazan fumarate

    Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group

  • DrugAmoxicillin,Furazolidone and Vonoprazan fumarate

    Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group

  • DrugTetracycline,Furazolidone and Vonoprazan fumarate

    Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group

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What researchers measure

Primary outcomes

  1. The most suitable re-eradication time

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

    Time frame: 1year

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Study locations

1 site
  • Qilu Hospital of Shandong University
    Jinan, Shandong 257000, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04810793
Lead sponsor
Shandong University
Collaborators
Taian City Central Hospital, Dezhou People's Hospital, Weifang Medical University, The Affiliated Hospital of Qingdao University, Shengli Oilfield Hospital
Responsible party
Xiuli Zuo (Professor, Director of gastroenterology department of Qilu hospital, Shandong University) — Principal investigator
First posted
Mar 23, 2021
Start date
Jul 1, 2020
Primary completion
Jun 1, 2022
Completion
Jun 30, 2022
Last update
Oct 27, 2022

Study contacts

Xiuli Zuo, MD,PhD
principal investigator · Qilu Hospital of Shandong University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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