The Study on the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure
1 other identifier
observational
820
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 21, 2021
CompletedFirst Posted
Study publicly available on registry
March 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedOctober 27, 2022
October 1, 2022
1.9 years
March 21, 2021
October 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The most suitable re-eradication time
The most suitable re-eradication time will be assessed by paired comparison method .
1year
Study Arms (6)
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.
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.
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.
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.
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.
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.
Interventions
Esomeprazole-Bismuth-Amoxicillin-Levofloxacin-containing quadruple regimens
Esomeprazole-Bismuth-Amoxicillin-Furazolidone-containing quadruple regimens
Esomeprazole-Bismuth-Tetracycline-Furazolidone-containing quadruple regimens
Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group
Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group
Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group
Eligibility Criteria
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 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shandong Universitylead
- Taian City Central Hospitalcollaborator
- Dezhou People's Hospitalcollaborator
- Weifang Medical Universitycollaborator
- The Affiliated Hospital of Qingdao Universitycollaborator
- Shengli Oilfield Hospitalcollaborator
Study Sites (1)
Qilu Hospital of Shandong University
Jinan, Shandong, 257000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiuli Zuo, MD,PhD
Qilu Hospital of Shandong University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director of gastroenterology department of Qilu hospital
Study Record Dates
First Submitted
March 21, 2021
First Posted
March 23, 2021
Study Start
July 1, 2020
Primary Completion
June 1, 2022
Study Completion
June 30, 2022
Last Updated
October 27, 2022
Record last verified: 2022-10