Efficacy Analysis of Saccharomyces Boulardii Combined With Minocycline in Treatment-naïve Patients With Helicobacter Pylori Infection

Southeast University

Status: Not yet enrolling

Conditions: H. Pylori Infection

Treatments: Drug: Bismuth quadruple therapy; Drug: Saccharomyces boulardii

Study type: Interventional

Funder types: Other

Identifiers

NCT07012785

2025ZDSYLL071-P01

Details and patient eligibility

About

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

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18-70 years, regardless of gender;
2. Positive 13C/14C urea breath test result;
3. No previous history of H. pylori eradication treatment;
4. Agreement to participate in this study and signing of the informed consent form.

Exclusion criteria

1. History of ≥ 1 instance of failed H. pylori eradication;
2. 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;
3. Plans to conceive, pregnancy, or breastfeeding;
4. Severe liver, kidney, or cardiovascular diseases; malignancies; and alcoholism;
5. Allergies to the drugs used in this study or a history of penicillin allergy;
6. The inability to correctly express one's symptoms and wishes, such as inability due to mental illness or severe neurosis.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Control Group

Active Comparator group

Treatment:

Drug: Bismuth quadruple therapy

Experimental group

Experimental group

Treatment:

Drug: Saccharomyces boulardii