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

October 26, 2022 updated by: Xiuli Zuo, Shandong University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

820

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 257000
        • Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Esomeprazole-Bismuth-Amoxicillin-Levofloxacin-containing quadruple regimens
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
Esomeprazole-Bismuth-Amoxicillin-Furazolidone-containing quadruple regimens
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
Esomeprazole-Bismuth-Tetracycline-Furazolidone-containing quadruple regimens
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-Levofloxacin-Vonoprazan fumarate-containing quadruple group
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
Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group
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
Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The most suitable re-eradication time
Time Frame: 1year
The most suitable re-eradication time will be assessed by paired comparison method .
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

March 21, 2021

First Submitted That Met QC Criteria

March 21, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-SDU-QILU-G101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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