Helicobacter Pylori InfectionNCT05493644
A 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.
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?
- Remedial treatment within 3 months, Remedial treatment within 3 to 6 months and Remedial treatment within 6 to 12 months
- How many people
- 660 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 31 Dec 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: Patients aged 18-70 with previous Helicobacter pylori eradication failure.
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.
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
- Remedial treatment within 3 months, Remedial treatment within 3 to 6 months, Remedial treatment within 6 to 12 months, Remedial treatment after 12 months
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remedial treatment within 3 monthsOther
Remedial therapy was performed within 3 months
Remedial treatment within 3 to 6 monthsOther
Remedial therapy was performed within 3 to 6 months
Remedial treatment within 6 to 12 monthsOther
Remedial therapy was performed within 6 to 12 months
Remedial treatment after 12 monthsOther
Remedial therapy was performed after 12 months
| Study group | Role | What they receive |
|---|---|---|
| group A | Within 3 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d. Receives: Other: Remedial treatment within 3 months | |
| group B | Within 3 to 6 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d. Receives: Other: Remedial treatment within 3 to 6 months | |
| group C | Within 6 to 12 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d. Receives: Other: Remedial treatment within 6 to 12 months | |
| group D | After 12 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d. Receives: Other: Remedial treatment after 12 months |
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: 12 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: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493644
- Sponsor's protocol ID
- 2022-SDU-QILU-G808
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure
- ClinicalTrials.gov ID
- NCT05493644
- Acronym / sponsor ID
- 2022-SDU-QILU-G808
- Conditions
- Helicobacter Pylori Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Aug 2022 (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
- 4
| Arm | Type | Receives |
|---|---|---|
| group A | – | Other: Remedial treatment within 3 monthsWithin 3 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d. |
| group B | – | Other: Remedial treatment within 3 to 6 monthsWithin 3 to 6 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d. |
| group C | – | Other: Remedial treatment within 6 to 12 monthsWithin 6 to 12 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d. |
| group D | – | Other: Remedial treatment after 12 monthsAfter 12 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-70 with previous Helicobacter pylori eradication failure.
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 |
|---|---|---|
| Remedial treatment within 3 monthsRemedial therapy was performed within 3 months | Other | group A |
| Remedial treatment within 3 to 6 monthsRemedial therapy was performed within 3 to 6 months | Other | group B |
| Remedial treatment within 6 to 12 monthsRemedial therapy was performed within 6 to 12 months | Other | group C |
| Remedial treatment after 12 monthsRemedial therapy was performed after 12 months | Other | group D |
Primary outcome
The most suitable re-eradication time
Time frame: 12 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: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection, run by Shandong University.
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: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2022.