Helicobacter Pylori InfectionNCT05173493
The Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure
An observational study of Helicobacter Pylori Infection, run by Shandong University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Amoxicillin,Furazolidone, Amoxicillin,Levofloxacin and Tetracycline,Furazolidone
- How many people
- 670 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2021to 10 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients aged 18-70 with H. pylori infection.
- Patients with previous Helicobacter pylori eradication.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 inpatients with Hp eradication failure.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Amoxicillin,Furazolidone, Amoxicillin,Levofloxacin, Tetracycline,Furazolidone
- Keywords
- Helicobacter pylori, Re-eradication time, Remedial treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin,FurazolidoneDrug
Amoxicillin-Furazolidone-containing quadruple group
Amoxicillin,LevofloxacinDrug
Amoxicillin-Levofloxacin-containing quadruple group
Tetracycline,FurazolidoneDrug
Tetracycline-Furazolidone-containing quadruple group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Tetracycline,Furazolidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The most suitable re-eradication time
The most suitable re-eradication time（The unit is month） will be assessed by paired comparison method .
Measured: 6 months
Secondary outcomes (1)
Eradication rates in three groups
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in three groups.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start30 Dec 2021
- Primary completion10 Feb 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Taian City Central Hospital, Dezhou People's Hospital, Weifang Medical University, The Affiliated Hospital of Qingdao University, Shengli Oilfield Hospital
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
- Investigators
- Xiuli Zuo, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173493
- Sponsor's protocol ID
- 2021-SDU-QILU-G101
- Status last verified
- Feb 2023
- First submitted
- 28 Dec 2021
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40304303
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure
- ClinicalTrials.gov ID
- NCT05173493
- Acronym / sponsor ID
- 2021-SDU-QILU-G101
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Re-eradication time, Remedial treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Taian City Central Hospital, Dezhou People's Hospital, Weifang Medical University, The Affiliated Hospital of Qingdao University, Shengli Oilfield Hospital
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 inpatients with Hp eradication failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin-Furazolidone-containing quadruple group | – | Drug: Amoxicillin,FurazolidonePatients 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. |
| Amoxicillin-Levofloxacin-containing quadruple group | – | Drug: Amoxicillin,LevofloxacinPatients 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. |
| Tetracycline-Furazolidone-containing quadruple group | – | Drug: Tetracycline,FurazolidonePatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients aged 18-70 with H. pylori infection.
- Patients with previous Helicobacter pylori eradication.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin,FurazolidoneAmoxicillin-Furazolidone-containing quadruple group | Drug | Amoxicillin-Furazolidone-containing quadruple group |
| Amoxicillin,LevofloxacinAmoxicillin-Levofloxacin-containing quadruple group | Drug | Amoxicillin-Levofloxacin-containing quadruple group |
| Tetracycline,FurazolidoneTetracycline-Furazolidone-containing quadruple group | Drug | Tetracycline-Furazolidone-containing quadruple group |
Primary outcome
The most suitable re-eradication time
Time frame: 6 months
The most suitable re-eradication time（The unit is month） will be assessed by paired comparison method .
1 secondary outcome
Eradication rates in three groups
Time frame: 6months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Derived from this study: PubMed 40304303Lin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuli Zuo principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The most suitable re-eradication time (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05173493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.