Gut MicrobiotaNCT06292546
The Effects of High-dose Dual Therapy With Probiotics on Gut Microbiota for Helicobacter Pylori Rescue Treatment
A study testing Vonoprazan, Amoxicillin and Bacillus subtilis enteric-coated capsules in people with Gut Microbiota and Metabolic Disturbance, run by Zhongshan Hospital (Xiamen), Fudan University at 1 site in China.
Trial summary
The aim of this study was to evaluate the effects of High-dose Dual therapy combined with probiotics on the gut microbiota for Helicobacter pylori rescue treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gut Microbiota, Metabolic Disturbance, Helicobacter Pylori Eradication
- What is being tested?
- Vonoprazan, Amoxicillin and Bacillus subtilis enteric-coated capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 28 Feb 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years;
- H.pylori infection diagnosed by 13C-urea breath test;
- A period of more than two months since the last eradication therapy for H. pylori;
- Patients who had previously failed 2 or more eradication regimens.
Who cannot join
- Allergy to any of the medications;
- Zollinger-Ellison syndrome, GC, Upper gastrointestinal bleeding, or Active peptic ulcer;
- Coexistence of significant concomitant illnesses, including heart disease, renal failure, hepatic disease, previous abdominal surgery, lactation, or pregnancy;
- Patients who had used probiotics, vonoprazan, and antibiotics in the past 12 weeks;
- Unwillingness to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital (Xiamen), Fudan University
Xiamen, Fujian, 361015
About this study
Official title: The Effects of High-dose Dual Therapy Combined With Probiotics on Gut Microbiota for Helicobacter Pylori Rescue Treatment: A Prospective, Multicenter, Randomized Trial
The aim of this study was to evaluate the effects of High-dose Dual therapy combined with probiotics on the gut microbiota for Helicobacter pylori rescue treatment.
Read the detailed description
The combination of vonoprazan (VPZ) and amoxicillin (VA therapy) has been shown to achieve notable eradication rates for Helicobacter pylori (H. pylori). Patients who receive this treatment are prone to adverse reactions, such as diarrhea, abdominal distention. We plan to combine probiotic with the above treatment. However, it is not clear what changes in gut microbiota and metabolism may result from this therapy.
- Being tested
- Vonoprazan, Amoxicillin, Bacillus subtilis enteric-coated capsules
- Keywords
- Helicobacter pylori, Eradication, Vonoprazan, Amoxicillin, Gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Group A: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group B: vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C: 2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.
AmoxicillinDrug
Group A: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group B: vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C: 2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.
Bacillus subtilis enteric-coated capsulesDrug
Group A: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group B: vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C: 2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Receives: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Bacillus subtilis enteric-coated capsules |
| Group B | Experimental | vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Receives: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Bacillus subtilis enteric-coated capsules |
| Group C | Experimental | 2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. Receives: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Bacillus subtilis enteric-coated capsules |
| Group D | Active comparator | vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. Receives: Drug: Vonoprazan; Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiota
Diversity and Compositional Analysis of Gut Microbiota is tested by Metagenomics.
Measured: day 0, day 44 (or 58), day 104 (or 118)
Secondary outcomes (5)
Fecal Metabolites
Fecal metabolites is tested by Gas Chromatography-Mass Spectrometry Analysis.
Measured: day 0, day 44 (or 58), day 104 (or 118)
Eradication rate
Eradication rate of H pylori, presenting with negative results on the 13C-UBT test.
Measured: day 44 or day 58
Frequency of the adverse events
Incidence rate of the adverse events, including dyspepsia, nausea, vomiting, abdominal pain, bloating, diarrhea, dizziness, headache, skin rash, fatigue and fever.
Measured: day 44 or day 58
Compliance rate of the drugs
Compliance is defined as good when they had taken more than 80% of the total medication.
Measured: day 44 or day 58
Small intestinal bacterial overgrowth
Small intestinal bacterial overgrowth is tested by Hydrogen-Methane Breath.
Measured: day 0, day 44 (or 58), day 104 (or 118)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start31 Jan 2024
- Primary completion30 Dec 2024
- Study completion28 Feb 2025
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 Gut MicrobiotaStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongshan Hospital (Xiamen), Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuyucheng, Zhongshan Hospital (Xiamen), Fudan University
- Investigators
- Yucheng Zhu, Ph.D., Principal investigator, Zhongshan Hospital (Xiamen), Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292546
- Sponsor's protocol ID
- ZYC-Hp2024
- Status last verified
- May 2025
- First submitted
- 19 Feb 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We may balance the potential benefits and risks for each request and then provide the data that could be shared.
Publications
Hu Y, Xu X, Ouyang YB, He C, Li NS, Xie C, Peng C, Zhu ZH, Shu X, Xie Y, Lu NH, Zhu Y. Altered Gut Microbiota and Short-Chain Fatty Acids After Vonoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Eradication. Front Cell Infect Microbiol. 2022 Jun 2;12:881968. doi: 10.3389/fcimb.2022.881968. eCollection 2022.
PubMed 35719338
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High-dose Dual Therapy Combined With Probiotics on Gut Microbiota for Helicobacter Pylori Rescue Treatment: A Prospective, Multicenter, Randomized Trial
- ClinicalTrials.gov ID
- NCT06292546
- Acronym / sponsor ID
- ZYC-Hp2024
- Keywords
- Helicobacter pylori, Eradication, Vonoprazan, Amoxicillin, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Zhongshan Hospital (Xiamen), Fudan UniversityUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 5 Mar 2024 (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 aim of this study was to evaluate the effects of High-dose Dual therapy combined with probiotics on the gut microbiota for Helicobacter pylori rescue treatment.
Detailed description
The combination of vonoprazan (VPZ) and amoxicillin (VA therapy) has been shown to achieve notable eradication rates for Helicobacter pylori (H. pylori). Patients who receive this treatment are prone to adverse reactions, such as diarrhea, abdominal distention. We plan to combine probiotic with the above treatment. However, it is not clear what changes in gut microbiota and metabolism may result from this therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Vonoprazan, Drug: Amoxicillin, Drug: Bacillus subtilis enteric-coated capsulesvonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days. |
| Group B | Experimental | Drug: Vonoprazan, Drug: Amoxicillin, Drug: Bacillus subtilis enteric-coated capsulesvonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. |
| Group C | Experimental | Drug: Vonoprazan, Drug: Amoxicillin, Drug: Bacillus subtilis enteric-coated capsules2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. |
| Group D | Active comparator | Drug: Vonoprazan, Drug: Amoxicillinvonoprazan 20 mg bid + amoxicillin 0.75 g qid 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)
- Age from 18 to 65 years;
- H.pylori infection diagnosed by 13C-urea breath test;
- A period of more than two months since the last eradication therapy for H. pylori;
- Patients who had previously failed 2 or more eradication regimens.
Key exclusion criteria (5 listed)
- Allergy to any of the medications;
- Zollinger-Ellison syndrome, GC, Upper gastrointestinal bleeding, or Active peptic ulcer;
- Coexistence of significant concomitant illnesses, including heart disease, renal failure, hepatic disease, previous abdominal surgery, lactation, or pregnancy;
- Patients who had used probiotics, vonoprazan, and antibiotics in the past 12 weeks;
- Unwillingness to participate in this study.
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 |
|---|---|---|
| VonoprazanGroup A: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group B: vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C: 2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. | Drug | Group A, Group B, Group C, Group D |
| AmoxicillinGroup A: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group B: vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C: 2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. | Drug | Group A, Group B, Group C, Group D |
| Bacillus subtilis enteric-coated capsulesGroup A: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days, followed by 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group B: vonoprazan 20 mg bid + amoxicillin 0.75 g qid+ 2 doses of bacillus subtilis enteric-coated capsules for 14 days. Group C: 2 doses of bacillus subtilis enteric-coated capsules for 14 days, followed by vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. Group D: vonoprazan 20 mg bid + amoxicillin 0.75 g qid for 14 days. | Drug | Group A, Group B, Group C |
Primary outcome
Gut Microbiota
Time frame: day 0, day 44 (or 58), day 104 (or 118)
Diversity and Compositional Analysis of Gut Microbiota is tested by Metagenomics.
5 secondary outcomes
Fecal Metabolites
Time frame: day 0, day 44 (or 58), day 104 (or 118)
Eradication rate
Time frame: day 44 or day 58
Frequency of the adverse events
Time frame: day 44 or day 58
Compliance rate of the drugs
Time frame: day 44 or day 58
Small intestinal bacterial overgrowth
Time frame: day 0, day 44 (or 58), day 104 (or 118)
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 13 May 2025.
- Results publication: PubMed 35719338Hu Y, Xu X, Ouyang YB, He C, Li NS, Xie C, Peng C, Zhu ZH, Shu X, Xie Y, Lu NH, Zhu Y. Altered Gut Microbiota and Short-Chain Fatty Acids After Vonoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Eradication. Front Cell Infect Microbiol. 2022 Jun 2;12:881968. doi: 10.3389/fcimb.2022.881968. eCollection 2022.
- Individual participant dataSharing planned: No. We may balance the potential benefits and risks for each request and then provide the data that could be shared.
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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.
Yucheng Zhu, Ph.D. principal investigator
Zhongshan Hospital (Xiamen), Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vonoprazan, Amoxicillin and Bacillus subtilis enteric-coated capsules in people with Gut Microbiota and Metabolic Disturbance, run by Zhongshan Hospital (Xiamen), Fudan 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 5 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 13 May 2025. 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?
Gut Microbiota (time frame: day 0, day 44 (or 58), day 104 (or 118)). 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 NCT06292546, 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 13 May 2025.