NCT05173493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
670

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

December 30, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

December 28, 2021

Last Update Submit

February 16, 2023

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pyloriRe-eradication timeRemedial treatment

Outcome Measures

Primary Outcomes (1)

  • The most suitable re-eradication time

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

    6 months

Secondary Outcomes (1)

  • Eradication rates in three groups

    6months

Study Arms (3)

Amoxicillin-Furazolidone-containing quadruple group

Patients in amoxicillin-furazolidone-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid(or vonoprazan fumarate 20mg po bid), amoxicillin1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.

Drug: Amoxicillin,Furazolidone

Amoxicillin-Levofloxacin-containing quadruple group

Patients in amoxicillin-Levofloxacin-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid(or vonoprazan fumarate 20mg po bid), amoxicillin1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd for 14d.

Drug: Amoxicillin,Levofloxacin

Tetracycline-Furazolidone-containing quadruple group

Patients in tetracycline-furazolidone-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid(or vonoprazan fumarate 20mg po bid), tetracycline 500 mg po qid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.

Drug: Tetracycline,Furazolidone

Interventions

Amoxicillin,FurazolidoneDRUG

Amoxicillin-Furazolidone-containing quadruple group

Amoxicillin-Furazolidone-containing quadruple group
Amoxicillin,LevofloxacinDRUG

Amoxicillin-Levofloxacin-containing quadruple group

Amoxicillin-Levofloxacin-containing quadruple group
Tetracycline,FurazolidoneDRUG

Tetracycline-Furazolidone-containing quadruple group

Tetracycline-Furazolidone-containing quadruple group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Related Publications (1)

  • Lin M, Hu J, Liu J, Wang J, Han Z, Wang X, Zhai Z, Yu Y, Yuan W, Zhang W, Wang Z, Kong Q, Lin B, Ding Y, Wan M, Zhang W, Duan M, Zeng S, Li Y, Zuo X, Li Y. The interval of rescue treatment does not affect the efficacy and safety of Helicobacter pylori eradication: A prospective multicenter observational study. Chin Med J (Engl). 2025 Jun 20;138(12):1439-1446. doi: 10.1097/CM9.0000000000003534. Epub 2025 Apr 29.

    PMID: 40304303DERIVED

MeSH Terms

Interventions

AmoxicillinFurazolidoneLevofloxacinTetracycline

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitrofuransNitro CompoundsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingFuransOfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Xiuli Zuo

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director of gastroenterology department of Qilu hospita

Study Record Dates

First Submitted

December 28, 2021

First Posted

December 30, 2021

Study Start

December 30, 2021

Primary Completion

February 10, 2023

Study Completion

February 10, 2023

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations

CN(1)