Helicobacter Pylori InfectionNCT05097846
Differences in the Eradication of Helicobacter Pylori by Different Therapies
A study testing Group1 Vonoprazan Fumarate + amoxicillin + doxycycline, Group2 Vonoprazan Fumarate + furazolidone + doxycycline and Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline in people with Helicobacter Pylori Infection, run by wang xiaoyan at 1 site in China.
Trial summary
To compare the performance of four treatment regimens for radical treatment of Helicobacter pylori, evaluating the efficacy, safety, patient compliance, and socioeconomic evaluation of the four regimens. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Group1 Vonoprazan Fumarate + amoxicillin + doxycycline, Group2 Vonoprazan Fumarate + furazolidone + doxycycline and Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2021to 17 Oct 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, ≤80 years
- Urea breath test (UBT) was positive for Hp infection;
- WIthout any anti-Hp treatment before
- Endoscopy was performed within 1 month
- Understanding the purpose and procedure of the study, voluntarily participating in the study and signing a written informed consent.
Who cannot join
- Allergic to drugs used in this clinical study;
- Using PPI, histamine H2 receptor antagonist, antibiotics, bismuth, probiotics or drugs with antibacterial effects within 4 weeks before treatment.
- Using adrenal corticosteroids, non-steroidal anti-inflammatory drugs and anticoagulants
- The disease or clinical condition that may interfere with the treatment evaluation of the study, such as liver disease, cardiovascular disease, lung disease, kidney disease, metabolic disease, psychiatric disease, or malignant tumor
- Pregnant or lactating women
- Participated in other clinical studies within 3 months prior to the registration of this clinical study
- Suspected history of antibiotic abuse
- Patients with craniocerebral injury, mental illness or epilepsy who cannot communicate with others or other diseases that may affect follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The third Xiangya Hospital of central south University
Changsha, Hunan, 410003
Xiaoyan Wang, MD, +8613974889301, wangxiaoyan@csu.edu.cn
Zinan Zhang, MD, +8615273169959, classroom0705@163.com
About this study
Official title: Comparison of Vonoprazan Fumarate-based Triple Therapy Versus Proton Pump Inhibitor and Bismuth Based Quadruple Therapy in the Eradication of Helicobacter Pylori: a Single-center Prospective Open-label Controlled Study
To compare the performance of four treatment regimens for radical treatment of Helicobacter pylori, evaluating the efficacy, safety, patient compliance, and socioeconomic evaluation of the four regimens. The four treatment regimens included (1) Vonoprazan Fumarate + amoxicillin + doxycycline, (2) Vonoprazan Fumarate + furazolidone + doxycycline, (3) esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline, and (4) esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline.
Read the detailed description
A single-center, prospective, open-label, parallel control design was conducted to enroll 100 patients with confirmed Helicobacter pylori infection. Patients were randomly divided into four groups, respectively accept four treatment regimens including (1) Vonoprazan Fumarate + amoxicillin + doxycycline, (2) Vonoprazan Fumarate + furazolidone + doxycycline, (3) esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline, and (4) esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline. The effectiveness, safety and compliance of the four regimens were compared, and the cost-benefit analysis of the different regimens was conducted. The purpose of this study was to explore the most appropriate treatment plan for radical treatment of Helicobacter pylori .
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Group1 Vonoprazan Fumarate + amoxicillin + doxycycline, Group2 Vonoprazan Fumarate + furazolidone + doxycycline, Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline, Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group1 Vonoprazan Fumarate + amoxicillin + doxycyclineDrug
Vonoprazan Fumarate + amoxicillin + doxycycline
Group2 Vonoprazan Fumarate + furazolidone + doxycyclineDrug
Vonoprazan Fumarate + furazolidone + doxycycline
Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycyclineDrug
esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline
Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycyclineDrug
esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline
| Study group | Role | What they receive |
|---|---|---|
| Group1: Vonoprazan Fumarate + amoxicillin + doxycycline | Experimental | Not described Receives: Drug: Group1 Vonoprazan Fumarate + amoxicillin + doxycycline |
| Group2: Vonoprazan Fumarate + furazolidone + doxycycline | Experimental | Not described Receives: Drug: Group2 Vonoprazan Fumarate + furazolidone + doxycycline |
| Group3: esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline | Experimental | Not described Receives: Drug: Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline |
| Group4: esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline | Experimental | Not described Receives: Drug: Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate of Hp at one time
The UBT test was performed to determine whether Hp was eradicated. No antibiotics, bismuth, or PPI were taken during this period. ITT analysis and PP analysis were used.
Measured: 43 or 57 days after the initiation of eradication therapy
Secondary outcomes (2)
Cost-benefit analysis
The drug cost of the two treatment options was calculated. According to the HP eradication rate, markov model was used to conduct cost-benefit analysis of the two methods, and determine which method was more cost-effective from an economic perspective.
Measured: 43 or 57 days after the initiation of eradication therapy
Adverse events
Adverse drug events, significant laboratory outliers, and new diseases emerging during the study
Measured: 43 or 57 days after the initiation of eradication therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start17 Jun 2021
- Primary completion17 Jun 2022 (estimated)
- Study completion17 Oct 2022 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- wang xiaoyan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, wang xiaoyan, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097846
- Sponsor's protocol ID
- 2021HP
- Status last verified
- Feb 2022
- First submitted
- 16 Oct 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Z, Liu F, Ai F, Chen X, Liu R, Zhang C, Fang N, Fu T, Wang X, Tang A. The efficacy and mechanism of vonoprazan-containing triple therapy in the eradication of Helicobacter pylori. Front Pharmacol. 2023 May 5;14:1143969. doi: 10.3389/fphar.2023.1143969. eCollection 2023.
PubMed 37214450
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vonoprazan Fumarate-based Triple Therapy Versus Proton Pump Inhibitor and Bismuth Based Quadruple Therapy in the Eradication of Helicobacter Pylori: a Single-center Prospective Open-label Controlled Study
- ClinicalTrials.gov ID
- NCT05097846
- Acronym / sponsor ID
- 2021HP
- Conditions
- Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- wang xiaoyanUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 17 Jun 2022 (estimated)
- Study completion
- 17 Oct 2022 (estimated)
- First posted
- 28 Oct 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.
To compare the performance of four treatment regimens for radical treatment of Helicobacter pylori, evaluating the efficacy, safety, patient compliance, and socioeconomic evaluation of the four regimens. The four treatment regimens included (1) Vonoprazan Fumarate + amoxicillin + doxycycline, (2) Vonoprazan Fumarate + furazolidone + doxycycline, (3) esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline, and (4) esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline.
Detailed description
A single-center, prospective, open-label, parallel control design was conducted to enroll 100 patients with confirmed Helicobacter pylori infection. Patients were randomly divided into four groups, respectively accept four treatment regimens including (1) Vonoprazan Fumarate + amoxicillin + doxycycline, (2) Vonoprazan Fumarate + furazolidone + doxycycline, (3) esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline, and (4) esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline. The effectiveness, safety and compliance of the four regimens were compared, and the cost-benefit analysis of the different regimens was conducted. The purpose of this study was to explore the most appropriate treatment plan for radical treatment of Helicobacter pylori .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1: Vonoprazan Fumarate + amoxicillin + doxycycline | Experimental | Drug: Group1 Vonoprazan Fumarate + amoxicillin + doxycycline |
| Group2: Vonoprazan Fumarate + furazolidone + doxycycline | Experimental | Drug: Group2 Vonoprazan Fumarate + furazolidone + doxycycline |
| Group3: esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline | Experimental | Drug: Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline |
| Group4: esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline | Experimental | Drug: Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years, ≤80 years
- Urea breath test (UBT) was positive for Hp infection;
- WIthout any anti-Hp treatment before
- Endoscopy was performed within 1 month
- Understanding the purpose and procedure of the study, voluntarily participating in the study and signing a written informed consent.
Key exclusion criteria (8 listed)
- Allergic to drugs used in this clinical study;
- Using PPI, histamine H2 receptor antagonist, antibiotics, bismuth, probiotics or drugs with antibacterial effects within 4 weeks before treatment.
- Using adrenal corticosteroids, non-steroidal anti-inflammatory drugs and anticoagulants
- The disease or clinical condition that may interfere with the treatment evaluation of the study, such as liver disease, cardiovascular disease, lung disease, kidney disease, metabolic disease, psychiatric disease, or malignant tumor
- Pregnant or lactating women
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 |
|---|---|---|
| Group1 Vonoprazan Fumarate + amoxicillin + doxycyclineVonoprazan Fumarate + amoxicillin + doxycycline | Drug | Group1: Vonoprazan Fumarate + amoxicillin + doxycycline |
| Group2 Vonoprazan Fumarate + furazolidone + doxycyclineVonoprazan Fumarate + furazolidone + doxycycline | Drug | Group2: Vonoprazan Fumarate + furazolidone + doxycycline |
| Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycyclineesomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline | Drug | Group3: esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline |
| Group4 esomeprazole + colloidal bismuth tartrate + furazolidone + doxycyclineesomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline | Drug | Group4: esomeprazole + colloidal bismuth tartrate + furazolidone + doxycycline |
Primary outcome
Eradication rate of Hp at one time
Time frame: 43 or 57 days after the initiation of eradication therapy
The UBT test was performed to determine whether Hp was eradicated. No antibiotics, bismuth, or PPI were taken during this period. ITT analysis and PP analysis were used.
2 secondary outcomes
Cost-benefit analysis
Time frame: 43 or 57 days after the initiation of eradication therapy
Adverse events
Time frame: 43 or 57 days after the initiation of eradication therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Derived from this study: PubMed 37214450Zhang Z, Liu F, Ai F, Chen X, Liu R, Zhang C, Fang N, Fu T, Wang X, Tang A. The efficacy and mechanism of vonoprazan-containing triple therapy in the eradication of Helicobacter pylori. Front Pharmacol. 2023 May 5;14:1143969. doi: 10.3389/fphar.2023.1143969. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group1 Vonoprazan Fumarate + amoxicillin + doxycycline, Group2 Vonoprazan Fumarate + furazolidone + doxycycline and Group3 esomeprazole + colloidal bismuth tartrate + amoxicillin + doxycycline in people with Helicobacter Pylori Infection, run by wang xiaoyan 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 5 inclusion and 8 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 18 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyan Wang, MD,PhD (+8613974889301, wangxiaoyan@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate of Hp at one time (time frame: 43 or 57 days after the initiation of eradication therapy). 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 NCT05097846, 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 18 Feb 2022.