Helicobacter Pylori InfectionPhase 4NCT05658055
The Effect of Probiotics on Gut Microbiotain After Helicobacter Pylori Eradication
A Phase 4 study testing Vonoprazan, Amoxicillin and probiotics in people with Helicobacter Pylori Infection and Infections, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect of probiotics during vonoprazan-amoxicillin dual therapy on the gut microbiota in Helicobacter pylori eradication and to investigate whether the eradication rate of H.pylori will be improved when adding probiotics Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection, Infections, Intestinal Bacteria Flora Disturbance
- What is being tested?
- Vonoprazan, Amoxicillin and probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 Dec 2023
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 18 and 65 years; Sexes eligible for study: both;
- patients who are diagnosed with Helicobacter pylori;
- treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months;
- voluntary to be involved in the study and written informed consent was obtained from all patients
Who cannot join
- allergic reactions to the study drugs;
- patients with peptic ulcer;
- patients who underwent eradication therapy for Helicobacter pylori during the last six months;
- patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment;
- patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
- patients who have history of esophageal or gastric surgery;
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- pregnant or lactating women;
- patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
- Alcohol abusers
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210000
Zhenyu Zhang, +86 025-87726248, zzy6565@sina.com
Zhibing Wang, +86 025-87726248, ahwangzhibing776@163.com
About this study
Official title: The Effect of Probiotics With Vonoprazan-amoxicillin Dual Therapy on Gut Microbiotain After Helicobacter Pylori Eradication: A Randomized Controlled Trial
The purpose of this study is to evaluate the effect of probiotics during vonoprazan-amoxicillin dual therapy on the gut microbiota in Helicobacter pylori eradication and to investigate whether the eradication rate of H.pylori will be improved when adding probiotics
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirement will be included in this simultaneous blind test. A total of 100 patients with HP infection were enrolled in this study. All patients were randomly divided into two groups according to the ratio of 1:1. Group A was given vonoprazan 20mg bid, amoxicillin 1000mg tid, Probiotics 3tabltes tid for 14 consecutive days; Group B was given vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days. On the 14th days of treatment, the researchers will follow up the patients' adverse reactions and medication compliance. The feces of the subjects were collected one day before the treatment, and on the 14th and 42th days after the treatment; After 4 weeks of drug withdrawal, all subjects will be reexamined with 13C-UBT.
- Being tested
- Vonoprazan, Amoxicillin, probiotics
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Potassium-competitive acid blocker
AmoxicillinDrug
Antibiotic for H. pylori eradication
probioticsDrug
Medilac-S; Enterococcus faecium 4.5*10^8 and Bacillus subtilis 5.0*10^7, Hanmi,Beijing, China
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin combined with vonoprazan | Active comparator | The subjects will be given 20mg vonoprazan twice a day and 1000mg amoxicillin three times a day. These two drugs were taken continuously for 14 days Receives: Drug: Vonoprazan; Drug: Amoxicillin |
| Probiotics combined with vonoprazan and amoxicillin | Experimental | The subjects will be given 20mg vonoprazan twice a day, 1000mg amoxicillin three times a day and probiotics three times a day. These three drugs were taken continuously for 14 days. Receives: Drug: Vonoprazan; Drug: Amoxicillin; Drug: probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of the gut microbiota composition
Stool samples were collected at the points of before eradication, after eradication and at confirmation. The gut microbiota composition of individuals was analyzed by 16S rRNA gene sequencing. Microbiome bioinformatics were performed with QIIME2 and R packages.
Measured: 12mouth
Secondary outcomes (2)
Helicobacter pylori eradication rate
Helicobacter pylori Eradication will be determined by ¹³C-urea breath test four to six weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
Measured: four to six weeks after completion of the medication
Adverse event
adverse events are recorded by the patient
Measured: one week after completion of the medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Jun 2023 (estimated)
- Primary completion31 Dec 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.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Zhenyu Zhang, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658055
- Sponsor's protocol ID
- KY20221124-08
- Status last verified
- Feb 2023
- First submitted
- 6 Dec 2022
- Last updated
- 8 Feb 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics With Vonoprazan-amoxicillin Dual Therapy on Gut Microbiotain After Helicobacter Pylori Eradication: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05658055
- Acronym / sponsor ID
- KY20221124-08
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Dec 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 purpose of this study is to evaluate the effect of probiotics during vonoprazan-amoxicillin dual therapy on the gut microbiota in Helicobacter pylori eradication and to investigate whether the eradication rate of H.pylori will be improved when adding probiotics
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirement will be included in this simultaneous blind test. A total of 100 patients with HP infection were enrolled in this study. All patients were randomly divided into two groups according to the ratio of 1:1. Group A was given vonoprazan 20mg bid, amoxicillin 1000mg tid, Probiotics 3tabltes tid for 14 consecutive days; Group B was given vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days. On the 14th days of treatment, the researchers will follow up the patients' adverse reactions and medication compliance. The feces of the subjects were collected one day before the treatment, and on the 14th and 42th days after the treatment; After 4 weeks of drug withdrawal, all subjects will be reexamined with 13C-UBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin combined with vonoprazan | Active comparator | Drug: Vonoprazan, Drug: AmoxicillinThe subjects will be given 20mg vonoprazan twice a day and 1000mg amoxicillin three times a day. These two drugs were taken continuously for 14 days |
| Probiotics combined with vonoprazan and amoxicillin | Experimental | Drug: Vonoprazan, Drug: Amoxicillin, Drug: probioticsThe subjects will be given 20mg vonoprazan twice a day, 1000mg amoxicillin three times a day and probiotics three times a day. These three drugs were taken continuously for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages between 18 and 65 years; Sexes eligible for study: both;
- patients who are diagnosed with Helicobacter pylori;
- treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months;
- voluntary to be involved in the study and written informed consent was obtained from all patients
Key exclusion criteria (9 listed)
- allergic reactions to the study drugs;
- patients with peptic ulcer;
- patients who underwent eradication therapy for Helicobacter pylori during the last six months;
- patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment;
- patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
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 |
|---|---|---|
| VonoprazanPotassium-competitive acid blocker | Drug | Amoxicillin combined with vonoprazan, Probiotics combined with vonoprazan and amoxicillin |
| AmoxicillinAntibiotic for H. pylori eradication | Drug | Amoxicillin combined with vonoprazan, Probiotics combined with vonoprazan and amoxicillin |
| probioticsMedilac-S; Enterococcus faecium 4.5*10^8 and Bacillus subtilis 5.0*10^7, Hanmi,Beijing, China | Drug | Probiotics combined with vonoprazan and amoxicillin |
Primary outcome
The comparison of the gut microbiota composition
Time frame: 12mouth
Stool samples were collected at the points of before eradication, after eradication and at confirmation. The gut microbiota composition of individuals was analyzed by 16S rRNA gene sequencing. Microbiome bioinformatics were performed with QIIME2 and R packages.
2 secondary outcomes
Helicobacter pylori eradication rate
Time frame: four to six weeks after completion of the medication
Adverse event
Time frame: one week after completion of the medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 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.
Zhenyu Zhang study chair
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vonoprazan, Amoxicillin and probiotics in people with Helicobacter Pylori Infection and Infections, run by Nanjing First Hospital, Nanjing Medical 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 4 inclusion and 9 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 8 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhenyu Zhang (+86 025-87726248, zzy6565@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The comparison of the gut microbiota composition (time frame: 12mouth). 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 8 Feb 2023.