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

Not Applicable

Not yet recruiting

• Conditions: H. Pylori Infection
• Interventions: Drug: Bismuth quadruple therapy; Drug: Saccharomyces boulardii

• Registration Number: NCT07012785
• Lead Sponsor: Zhongda Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06
• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Bismuth quadruple therapy	-
Experimental group	Saccharomyces boulardii	-

Primary Outcome Measures

Name	Time	Method
H. Pylori eradication rate	7 days

Trial Locations

Locations (1)

Zhongda Hospital Southeast University; 🇨🇳 Nanjing, Jiangsu, China