The Eradication Rate of Helicobacter PyloriNCT06004401
The Observation on the Efficacy of Dual Therapy Based on Vonoprazan in Eradicating Helicobacter Pylori
A study testing Vonopazan +Amoxicillin, Rabeprazole +colloidal pectin bismuth +Amoxicillin +Clarithromycin and Vonopazan +Minocycline in people with The Eradication Rate of Helicobacter Pylori, run by Shanghai Changzheng Hospital.
Trial summary
Helicobacter pylori（Hp）is listed as a Class 1 carcinogen by the International Agency for Research of Cancer (IARC), Eradicating Hp can significantly reduce the risk of gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- The Eradication Rate of Helicobacter Pylori
- What is being tested?
- Vonopazan +Amoxicillin, Rabeprazole +colloidal pectin bismuth +Amoxicillin +Clarithromycin and Vonopazan +Minocycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2023to 31 Dec 2025
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-75;
- Initial treatment patients with Helicobacter pylori infection (positive 13C carbon breath test/positive Hp in gastroscopy pathological biopsy);
- Not taking antibiotics, bismuth agents, or traditional Chinese medicine with antibacterial effects (Isatis indigotica, berberine, honeysuckle, forsythia suspensa) in the first 4 weeks; I did not take drugs that affect Hp activity such as PPI or H2 receptor antagonists in the first two weeks.
- -
Who cannot join
- 1）Age<18 years old or>75 years old; 2）Pregnant and lactating women; 3）Patients with severe primary diseases such as cardiovascular, liver, kidney, and hematopoietic systems, as well as mental illness.
- 4）History of Drug allergy used in the treatment.
About this study
Helicobacter pylori（Hp）is listed as a Class 1 carcinogen by the International Agency for Research of Cancer (IARC), Eradicating Hp can significantly reduce the risk of gastric cancer. In recent years, the resistance rate of Hp to antibiotics, especially Clarithromycin and Metronidazole, has increased, leading to the gradual reduction of the eradication rate . In addition, PPI is mainly metabolized by CYP2C19 in the body, and the genetic polymorphism of this enzyme activity in the population results in significant individual differences in the acid suppression effect of PPI; At the same time, PPI will affect the metabolism of other drugs by affecting the activity of CYP2C19 in the liver.
Potassium ion competitive acid blockers (P-CABs) are a new type of antacids, and vonoprazan is a representative of this class of drugs. Compared to traditional proton pump inhibitors, it has higher selectivity towards proton pumps, stronger acid inhibition effect, faster onset time , longer sustained acid inhibition time, and less influence from food consumption. Therefore, it can effectively eliminate Helicobacter pylori . In recent years, Vonoprazan has been widely used in the eradication treatment of Hp . Vonoprazan can inhibit gastric acid secretion more strongly and persistently, therefore, eradication plans based on vonoprazan are expected to improve the eradication rate of Hp.
Read more
Related studies have shown that compared to traditional proton pump inhibitors, vonoprazan has a more significant therapeutic effect and higher safety in the treatment of Helicobacter pylori positive peptic ulcers due to its unique mechanism of action..In recent years, there have been reports of successful eradication of multi drug resistant Hp retreated patients with Semisynthesis tetracycline. Some domestic scholars are also gradually trying to use Semisynthesis tetracycline to eradicate Hp infection. Minocycline is a Semisynthesis tetracycline. The drug sensitivity test in vitro showed that the resistance rate of Hp to Minocycline was low , suggesting that Minocycline may have a better effect on eradicating Hp.
Therefore, the investigators further carried out a prospective single center clinical study and set up a penicillin negative group. One month after treatment, 13C carbon breath test was performed to check the efficacy, in order to explore the efficacy of the combination therapy based on vonoprazan in eradicating Hp, especially whether it is a good choice for penicillin allergy.
Read the detailed description
After one month of treatment, a 13C carbon breath test was conducted to investigate the efficacy of a dual therapy based on vorolaxen in eradicating Hp, especially for those allergic to penicillin.
- Being tested
- Vonopazan +Amoxicillin, Rabeprazole +colloidal pectin bismuth +Amoxicillin +Clarithromycin, Vonopazan +Minocycline, Rabeprazole +colloidal pectin bismuth +Metronidazole +Clarithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonopazan +AmoxicillinDrug
Vonopazan 20mg 2//day+Amoxicillin
Rabeprazole +colloidal pectin bismuth +Amoxicillin +ClarithromycinDrug
Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Amoxicillin 1g 2/day+Clarithromycin 500mg 2/day
Vonopazan +MinocyclineDrug
Vonopazan 20mg 2/day+Minocycline 100mg 2/day
Rabeprazole +colloidal pectin bismuth +Metronidazole +ClarithromycinDrug
Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Metronidazole 0.4g 3/day+Clarithromycin 500mg 2/day
| Study group | Role | What they receive |
|---|---|---|
| Penicillin negative test group | Experimental | （Vonopazan 20mg 2//day+Amoxicillin 1.0g 3/day）*14 days Receives: Drug: Vonopazan +Amoxicillin |
| Penicillin negative contral group | Active comparator | （Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Amoxicillin 1g 2/day+Clarithromycin 500mg 2/day）*14 days Receives: Drug: Rabeprazole +colloidal pectin bismuth +Amoxicillin +Clarithromycin |
| Penicillin positive test group | Experimental | （Vonopazan 20mg 2/day+Minocycline 100mg 2/day）*14 days Receives: Drug: Vonopazan +Minocycline |
| Penicillin positive control group | Active comparator | （Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Metronidazole 0.4g 3/day+Clarithromycin 500mg 2/day）*14 days Receives: Drug: Rabeprazole +colloidal pectin bismuth +Metronidazole +Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The eradication rate of Helicobacter pylori
whether the dual therapy based on vorolaxen has advantages over traditional quadruple therapy in penicillin negative and positive patients
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start20 Aug 2023 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Eradication Rate of Helicobacter PyloriStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Fen Xie, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004401
- Sponsor's protocol ID
- CZHX2023.07
- Status last verified
- Aug 2023
- First submitted
- 30 Jul 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Observation on the Efficacy of Dual Therapy Based on Vonoprazan in Eradicating Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT06004401
- Acronym / sponsor ID
- CZHX2023.07
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 20 Aug 2023 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Aug 2023 (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.
Helicobacter pylori（Hp）is listed as a Class 1 carcinogen by the International Agency for Research of Cancer (IARC), Eradicating Hp can significantly reduce the risk of gastric cancer. In recent years, the resistance rate of Hp to antibiotics, especially Clarithromycin and Metronidazole, has increased, leading to the gradual reduction of the eradication rate . In addition, PPI is mainly metabolized by CYP2C19 in the body, and the genetic polymorphism of this enzyme activity in the population results in significant individual differences in the acid suppression effect of PPI; At the same time, PPI will affect the metabolism of other drugs by affecting the activity of CYP2C19 in the liver.
Potassium ion competitive acid blockers (P-CABs) are a new type of antacids, and vonoprazan is a representative of this class of drugs. Compared to traditional proton pump inhibitors, it has higher selectivity towards proton pumps, stronger acid inhibition effect, faster onset time , longer sustained acid inhibition time, and less influence from food consumption. Therefore, it can effectively eliminate Helicobacter pylori . In recent years, Vonoprazan has been widely used in the eradication treatment of Hp . Vonoprazan can inhibit gastric acid secretion more strongly and persistently, therefore, eradication plans based on vonoprazan are expected to improve the eradication rate of Hp.
Related studies have shown that compared to traditional proton pump inhibitors, vonoprazan has a more significant therapeutic effect and higher safety in the treatment of Helicobacter pylori positive peptic ulcers due to its unique mechanism of action..In recent years, there have been reports of successful eradication of multi drug resistant Hp retreated patients with Semisynthesis tetracycline. Some domestic scholars are also gradually trying to use Semisynthesis tetracycline to eradicate Hp infection. Minocycline is a Semisynthesis tetracycline. The drug sensitivity test in vitro showed that the resistance rate of Hp to Minocycline was low , suggesting that Minocycline may have a better effect on eradicating Hp.
Therefore, the investigators further carried out a prospective single center clinical study and set up a penicillin negative group. One month after treatment, 13C carbon breath test was performed to check the efficacy, in order to explore the efficacy of the combination therapy based on vonoprazan in eradicating Hp, especially whether it is a good choice for penicillin allergy.
Detailed description
After one month of treatment, a 13C carbon breath test was conducted to investigate the efficacy of a dual therapy based on vorolaxen in eradicating Hp, especially for those allergic to penicillin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Penicillin negative test group | Experimental | Drug: Vonopazan +Amoxicillin（Vonopazan 20mg 2//day+Amoxicillin 1.0g 3/day）*14 days |
| Penicillin negative contral group | Active comparator | Drug: Rabeprazole +colloidal pectin bismuth +Amoxicillin +Clarithromycin（Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Amoxicillin 1g 2/day+Clarithromycin 500mg 2/day）*14 days |
| Penicillin positive test group | Experimental | Drug: Vonopazan +Minocycline（Vonopazan 20mg 2/day+Minocycline 100mg 2/day）*14 days |
| Penicillin positive control group | Active comparator | Drug: Rabeprazole +colloidal pectin bismuth +Metronidazole +Clarithromycin（Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Metronidazole 0.4g 3/day+Clarithromycin 500mg 2/day）*14 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18-75;
- Initial treatment patients with Helicobacter pylori infection (positive 13C carbon breath test/positive Hp in gastroscopy pathological biopsy);
- Not taking antibiotics, bismuth agents, or traditional Chinese medicine with antibacterial effects (Isatis indigotica, berberine, honeysuckle, forsythia suspensa) in the first 4 weeks; I did not take drugs that affect Hp activity such as PPI or H2 receptor antagonists in the first two weeks.
- -
Key exclusion criteria (2 listed)
- 4）History of Drug allergy used in the treatment.
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 |
|---|---|---|
| Vonopazan +AmoxicillinVonopazan 20mg 2//day+Amoxicillin | Drug | Penicillin negative test group |
| Rabeprazole +colloidal pectin bismuth +Amoxicillin +ClarithromycinRabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Amoxicillin 1g 2/day+Clarithromycin 500mg 2/day | Drug | Penicillin negative contral group |
| Vonopazan +MinocyclineVonopazan 20mg 2/day+Minocycline 100mg 2/day | Drug | Penicillin positive test group |
| Rabeprazole +colloidal pectin bismuth +Metronidazole +ClarithromycinRabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Metronidazole 0.4g 3/day+Clarithromycin 500mg 2/day | Drug | Penicillin positive control group |
Primary outcome
The eradication rate of Helicobacter pylori
Time frame: two years
whether the dual therapy based on vorolaxen has advantages over traditional quadruple therapy in penicillin negative and positive patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for The Eradication Rate of Helicobacter Pylori
RecruitingPhase 4
CURE-H. Pylori: A Trial on the Combination of Anti-Ulcerants and Levofloxacin-Based Therapy for Helicobacter Pylori Eradication
H. Pylori Gastrointestinal Disease, H.Pylori Infection
Enrolling by invitation
to Assess the Eradication Rate of 14-day Bismuth/Amoxicillin/PCAB Triple Therapy for the Treatment of Helicobacter Pylori Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Vonopazan +Amoxicillin, Rabeprazole +colloidal pectin bismuth +Amoxicillin +Clarithromycin and Vonopazan +Minocycline in people with The Eradication Rate of Helicobacter Pylori, run by Shanghai Changzheng Hospital.
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 4 inclusion and 2 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 22 Aug 2023. 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 eradication rate of Helicobacter pylori (time frame: two years). 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 22 Aug 2023.