H. Pylori InfectionNCT07012785
Efficacy Analysis of Saccharomyces Boulardii Combined With Minocycline in Treatment-naïve Patients With Helicobacter Pylori Infection
A study testing Bismuth quadruple therapy and Saccharomyces boulardii in people with H. Pylori Infection, run by Zhongda Hospital at 1 site in China.
Trial summary
To assess the efficacy and safety of Saccharomyces boulardii combined with triple therapy containing minocycline in the initial eradication of Helicobacter pylori (H. pylori) infection Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- H. Pylori Infection
- What is being tested?
- Bismuth quadruple therapy and Saccharomyces boulardii
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- Jun 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 18-70 years, regardless of gender;
- Positive 13C/14C urea breath test result;
- No previous history of H. pylori eradication treatment;
- Agreement to participate in this study and signing of the informed consent form.
Who cannot join
- History of ≥ 1 instance of failed H. pylori eradication;
- Use of antibiotics (including antibacterial traditional Chinese medicines), nonsteroidal anti-inflammatory drugs (NSAIDS), bismuth agents, H2 receptor antagonists (H2RAs), proton-pump inhibitors (PPIs), and potassium-competitive acid blockers (P-CAB) within 4 weeks before treatment;
- Plans to conceive, pregnancy, or breastfeeding;
- Severe liver, kidney, or cardiovascular diseases; malignancies; and alcoholism;
- Allergies to the drugs used in this study or a history of penicillin allergy;
- The inability to correctly express one's symptoms and wishes, such as inability due to mental illness or severe neurosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210000
Lu Chen, 13611569073, 13611569073@163.com
About this study
To assess the efficacy and safety of Saccharomyces boulardii combined with triple therapy containing minocycline in the initial eradication of Helicobacter pylori (H. pylori) infection
- Conditions
- H. Pylori Infection
- Being tested
- Bismuth quadruple therapy, Saccharomyces boulardii
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bismuth quadruple therapyDrug
Bismuth quadruple therapy
Saccharomyces boulardiiDrug
Saccharomyces boulardii
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Drug: Bismuth quadruple therapy |
| Experimental group | Experimental | Not described Receives: Drug: Saccharomyces boulardii |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. Pylori eradication rate
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H. 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Lu, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012785
- Sponsor's protocol ID
- 2025ZDSYLL071-P01
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Analysis of Saccharomyces Boulardii Combined With Minocycline in Treatment-naïve Patients With Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT07012785
- Acronym / sponsor ID
- 2025ZDSYLL071-P01
- Conditions
- H. Pylori Infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Jun 2025 (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 assess the efficacy and safety of Saccharomyces boulardii combined with triple therapy containing minocycline in the initial eradication of Helicobacter pylori (H. pylori) infection
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Bismuth quadruple therapy |
| Experimental group | Experimental | Drug: Saccharomyces boulardii |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-70 years, regardless of gender;
- Positive 13C/14C urea breath test result;
- No previous history of H. pylori eradication treatment;
- Agreement to participate in this study and signing of the informed consent form.
Key exclusion criteria (6 listed)
- History of ≥ 1 instance of failed H. pylori eradication;
- Use of antibiotics (including antibacterial traditional Chinese medicines), nonsteroidal anti-inflammatory drugs (NSAIDS), bismuth agents, H2 receptor antagonists (H2RAs), proton-pump inhibitors (PPIs), and potassium-competitive acid blockers (P-CAB) within 4 weeks before treatment;
- Plans to conceive, pregnancy, or breastfeeding;
- Severe liver, kidney, or cardiovascular diseases; malignancies; and alcoholism;
- Allergies to the drugs used in this study or a history of penicillin allergy;
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 |
|---|---|---|
| Bismuth quadruple therapyBismuth quadruple therapy | Drug | Control Group |
| Saccharomyces boulardiiSaccharomyces boulardii | Drug | Experimental group |
Primary outcome
H. Pylori eradication rate
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bismuth quadruple therapy and Saccharomyces boulardii in people with H. Pylori Infection, run by Zhongda Hospital 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 6 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: opening soon, as of the sponsor's last update on 10 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu Chen (13611569073, 13611569073@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H. Pylori eradication rate (time frame: 7 days). 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 10 Jun 2025.