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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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H. Pylori Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Group

Group Type ACTIVE_COMPARATOR

Bismuth quadruple therapy

Intervention Type DRUG

Bismuth quadruple therapy

Experimental group

Group Type EXPERIMENTAL

Saccharomyces boulardii

Intervention Type DRUG

Saccharomyces boulardii

Interventions

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Bismuth quadruple therapy

Intervention Type DRUG

Saccharomyces boulardii

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No