Helicobacter Pylori InfectionPhase 1/2NCT05461508
Fucoidan Assisted Eradication of Helicobacter Pylori
A Phase 1/2 study testing Amoxicillin combined with vonoprazan and fucoidan and Amoxicillin combined with vonoprazan in people with Helicobacter Pylori Infection and Intestinal Bacteria Flora Disturbance, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this study is to investigate whether the eradication rate of H.pylori will be improved when adding fucoidan to the duplex scheme combination of amoxicillin and vonoprazan, and to explore the effect of fucoidan on gastrointestinal flora of patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection, Intestinal Bacteria Flora Disturbance
- What is being tested?
- Amoxicillin combined with vonoprazan and fucoidan and Amoxicillin combined with vonoprazan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Jul 2024
- Phase
- Phase 1/2
- 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
Who may be able to join
- Age 18-65 years old;
- Patients diagnosed as HP positive;
- Patients who have not received HP eradication treatment in the past, or who have failed in the early eradication but have not received eradication treatment within half a year;
- Voluntarily participate in this trial and sign the informed consent form.
Who cannot join
- Allergic to the study drug (penicillin allergy, etc.);
- Patients with chronic gastritis and peptic ulcer;
- Patients who have received HP eradication treatment within half a year;
- Antibiotics and bismuth agents were used 4 weeks before the start of the study treatment, and histamine H2 receptor antagonists or PPIs were used 2 weeks before the start of the study treatment;
- Use adrenocortical hormones, non steroidal anti-inflammatory drugs or anticoagulants;
- History of esophageal or gastric surgery;
- Pregnant and lactating women;
- Suffering from serious accompanying diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210000
Zhenyu Zhang, Master, +8618951670222, zzy6565@sina.com
Wenjuan Wei, Doctor, +8618851009006, wjwei.hf@hotmail.com
About this study
Official title: Study on the Effect of Fucoidan Combined With the Eradication Program Containing Vonoprazan on H.Pylori Eradication Rate and Gastrointestinal Flora.
The purpose of this study is to investigate whether the eradication rate of H.pylori will be improved when adding fucoidan to the duplex scheme combination of amoxicillin and vonoprazan, and to explore the effect of fucoidan on gastrointestinal flora of patients.
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 60 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, fucoidan 1000mg bid for 14 consecutive days; Group B was given vonoprazan 20mg bid and amoxicillin 1000mg TID for 14 days. On the 10th and 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 44th days after the treatment; After 4 weeks of drug withdrawal, all subjects will be reexamined with 13C-UBT.
- Being tested
- Amoxicillin combined with vonoprazan and fucoidan, Amoxicillin combined with vonoprazan
- Keywords
- Helicobacter Pylori Infection, Eradication treatment, Amoxicillin, vonoprazan, Fucoidan, Intestinal flora
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin combined with vonoprazan and fucoidanBiological
Fucoidan was used in combination with amoxicillin and vonoprazan. The purpose of this study was to explore the effect of fucoidan on the eradication rate of Helicobacter pylori and the intestinal flora of subjects.
Amoxicillin combined with vonoprazanOther
Amoxicillin and vonoprazan were used as the study control group
| 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: Other: Amoxicillin combined with vonoprazan |
| Amoxicillin combined with vonoprazan and fucoidan | Experimental | The subjects will be given 20mg vonoprazan twice a day, 1000mg amoxicillin three times a day and fucoidan 1000mg twice a day. These three drugs were taken continuously for 14 days. Receives: Biological: Amoxicillin combined with vonoprazan and fucoidan |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare eradication rates of the two groups by 13C-UBT
Compare the eradication rate of Helicobacter pylori between the fucoidan containing group and the fucoidan free group
Measured: 6 weeks
Analysis of intestinal flora difference before and after eradication using 16s rRNA sequencing
Analyze and compare the early and long-term changes of intestinal flora before and after eradication. Explore the effect of fucoidan on intestinal flora of patients receiving eradication treatment.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Oct 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion31 Jul 2024 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461508
- Sponsor's protocol ID
- KY20220518-02-KS-01
- Status last verified
- Dec 2023
- First submitted
- 11 Jul 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Fucoidan Combined With the Eradication Program Containing Vonoprazan on H.Pylori Eradication Rate and Gastrointestinal Flora.
- ClinicalTrials.gov ID
- NCT05461508
- Acronym / sponsor ID
- KY20220518-02-KS-01
- Keywords
- Helicobacter Pylori Infection, Eradication treatment, Amoxicillin, vonoprazan, Fucoidan, Intestinal flora
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 18 Jul 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 investigate whether the eradication rate of H.pylori will be improved when adding fucoidan to the duplex scheme combination of amoxicillin and vonoprazan, and to explore the effect of fucoidan on gastrointestinal flora of patients.
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 60 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, fucoidan 1000mg bid for 14 consecutive days; Group B was given vonoprazan 20mg bid and amoxicillin 1000mg TID for 14 days. On the 10th and 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 44th 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 | Other: Amoxicillin combined with vonoprazanThe 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 |
| Amoxicillin combined with vonoprazan and fucoidan | Experimental | Biological: Amoxicillin combined with vonoprazan and fucoidanThe subjects will be given 20mg vonoprazan twice a day, 1000mg amoxicillin three times a day and fucoidan 1000mg twice a day. These three drugs were taken continuously for 14 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years old;
- Patients diagnosed as HP positive;
- Patients who have not received HP eradication treatment in the past, or who have failed in the early eradication but have not received eradication treatment within half a year;
- Voluntarily participate in this trial and sign the informed consent form.
Key exclusion criteria (8 listed)
- Allergic to the study drug (penicillin allergy, etc.);
- Patients with chronic gastritis and peptic ulcer;
- Patients who have received HP eradication treatment within half a year;
- Antibiotics and bismuth agents were used 4 weeks before the start of the study treatment, and histamine H2 receptor antagonists or PPIs were used 2 weeks before the start of the study treatment;
- Use adrenocortical hormones, 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 |
|---|---|---|
| Amoxicillin combined with vonoprazan and fucoidanFucoidan was used in combination with amoxicillin and vonoprazan. The purpose of this study was to explore the effect of fucoidan on the eradication rate of Helicobacter pylori and the intestinal flora of subjects. | Biological | Amoxicillin combined with vonoprazan and fucoidan |
| Amoxicillin combined with vonoprazanAmoxicillin and vonoprazan were used as the study control group | Other | Amoxicillin combined with vonoprazan |
Primary outcome
compare eradication rates of the two groups by 13C-UBT
Time frame: 6 weeks
Compare the eradication rate of Helicobacter pylori between the fucoidan containing group and the fucoidan free group
Analysis of intestinal flora difference before and after eradication using 16s rRNA sequencing
Time frame: 6 weeks
Analyze and compare the early and long-term changes of intestinal flora before and after eradication. Explore the effect of fucoidan on intestinal flora of patients receiving eradication treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
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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 Phase 1/2 study testing Amoxicillin combined with vonoprazan and fucoidan and Amoxicillin combined with vonoprazan in people with Helicobacter Pylori Infection and Intestinal Bacteria Flora Disturbance, 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 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 7 Dec 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare eradication rates of the two groups by 13C-UBT (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 7 Dec 2023.