Helicobacter PyloriNCT04810793
The Study on the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure
An observational study of Helicobacter Pylori, 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 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori
- What is being tested?
- Amoxicillin , Levofloxacin and Esomeprazole, Amoxicillin , Furazolidone and Esomeprazole and Tetracycline , Furazolidone and Esomeprazole
- How many people
- 820 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 Jun 2022
- How long will I take part?
- 2 Months
- 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
- Healthy volunteers accepted
- 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 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.
Who cannot join
- 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.
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 in patients with Hp eradication failure.
- Conditions
- Helicobacter Pylori
- Being tested
- Amoxicillin , Levofloxacin and Esomeprazole, Amoxicillin , Furazolidone and Esomeprazole, Tetracycline , Furazolidone and Esomeprazole, Amoxicillin,Levofloxacin and Vonoprazan fumarate, Amoxicillin,Furazolidone and Vonoprazan fumarate
- Keywords
- 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 , Levofloxacin and EsomeprazoleDrug
Esomeprazole-Bismuth-Amoxicillin-Levofloxacin-containing quadruple regimens
Amoxicillin , Furazolidone and EsomeprazoleDrug
Esomeprazole-Bismuth-Amoxicillin-Furazolidone-containing quadruple regimens
Tetracycline , Furazolidone and EsomeprazoleDrug
Esomeprazole-Bismuth-Tetracycline-Furazolidone-containing quadruple regimens
Amoxicillin,Levofloxacin and Vonoprazan fumarateDrug
Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group
Amoxicillin,Furazolidone and Vonoprazan fumarateDrug
Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group
Tetracycline,Furazolidone and Vonoprazan fumarateDrug
Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Amoxicillin , Levofloxacin and Esomeprazole | |
| 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. Receives: Drug: Amoxicillin , Furazolidone and Esomeprazole | |
| 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. Receives: Drug: Tetracycline , Furazolidone and Esomeprazole | |
| 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. Receives: Drug: Amoxicillin,Levofloxacin and Vonoprazan fumarate | |
| 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. Receives: Drug: Amoxicillin,Furazolidone and Vonoprazan fumarate | |
| 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. Receives: Drug: Tetracycline,Furazolidone and Vonoprazan fumarate |
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 will be assessed by paired comparison method .
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Jul 2020
- Primary completion1 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter PyloriStudies 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
- 820 participants (actual)
- Target duration
- 2 Months
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, MD,PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810793
- Sponsor's protocol ID
- 2020-SDU-QILU-G101
- Status last verified
- Oct 2022
- First submitted
- 21 Mar 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure
- ClinicalTrials.gov ID
- NCT04810793
- Acronym / sponsor ID
- 2020-SDU-QILU-G101
- Conditions
- Helicobacter Pylori
- Keywords
- Re-eradication time, Remedial treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 820 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
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 23 Mar 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 in patients with Hp eradication failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin-Levofloxacin-Esomeprazole-containing quadruple group | – | Drug: Amoxicillin , Levofloxacin and EsomeprazolePatients 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 | – | Drug: Amoxicillin , Furazolidone and EsomeprazolePatients 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 | – | Drug: Tetracycline , Furazolidone and EsomeprazolePatients 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 | – | Drug: Amoxicillin,Levofloxacin and Vonoprazan fumaratePatients 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 | – | Drug: Amoxicillin,Furazolidone and Vonoprazan fumaratePatients 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 | – | Drug: Tetracycline,Furazolidone and Vonoprazan fumaratePatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- 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 (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 , Levofloxacin and EsomeprazoleEsomeprazole-Bismuth-Amoxicillin-Levofloxacin-containing quadruple regimens | Drug | Amoxicillin-Levofloxacin-Esomeprazole-containing quadruple group |
| Amoxicillin , Furazolidone and EsomeprazoleEsomeprazole-Bismuth-Amoxicillin-Furazolidone-containing quadruple regimens | Drug | Amoxicillin-Furazolidone-Esomeprazole-containing quadruple group |
| Tetracycline , Furazolidone and EsomeprazoleEsomeprazole-Bismuth-Tetracycline-Furazolidone-containing quadruple regimens | Drug | Tetracycline-Furazolidone-Esomeprazole-containing quadruple group |
| Amoxicillin,Levofloxacin and Vonoprazan fumarateAmoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group | Drug | Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group |
| Amoxicillin,Furazolidone and Vonoprazan fumarateAmoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group | Drug | Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group |
| Tetracycline,Furazolidone and Vonoprazan fumarateTetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group | Drug | Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group |
Primary outcome
The most suitable re-eradication time
Time frame: 1year
The most suitable re-eradication time will be assessed by paired comparison method .
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 27 Oct 2022.
Related trials for Helicobacter Pylori
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
Not yet recruiting
Gastric String Test Combined With a Rapid Antigen Assay for Helicobacter Pylori Detection
Helicobacter Pylori
Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
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, MD,PhD 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, 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 1 inclusion and 1 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 27 Oct 2022. 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: 1year). 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 27 Oct 2022.