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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZhongda Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bismuth quadruple therapy

    Drug

    Bismuth quadruple therapy

  • Saccharomyces boulardii

    Drug

    Saccharomyces boulardii

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

H. Pylori eradication rate

Time frame
7 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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