Not yet recruiting NCT07012785
Efficacy Analysis of Saccharomyces Boulardii Combined With Minocycline in Treatment-naïve Patients With Helicobacter Pylori Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bismuth quadruple therapy, Saccharomyces boulardii.
- Who it may be relevant to
- Registry conditions: H. Pylori Infection. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Drug Bismuth quadruple therapy
Bismuth quadruple therapy - Drug Saccharomyces boulardii
Saccharomyces boulardii
Primary outcome measures
- H. Pylori eradication rate [Time frame: 7 days]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Zhongda Hospital Southeast University — Nanjing
Identifiers
NCT: NCT07012785 · 2025ZDSYLL071-P01