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Efficacy of Saccharomyces boulardii Combined with Bismuth-Containing Quadruple Therapy in the Treatment of Pediatric Helicobacter pylori-Associated Gastric Ulcer: A Randomized Controlled, Multicenter Clinical Study

Efficacy of Saccharomyces boulardii Combined with Bismuth-Containing Quadruple Therapy in the Treatment of Pediatric Helicobacter pylori-Associated Gastric Ulcer: A Randomized Controlled, Multicenter Clinical Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127614
Enrollment
Unknown
Registered
2026-07-02
Start date
2026-07-02
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori (Hp) infection

Interventions

Control group:Vonoprazan-Amoxicillin high-dose dual therapy Vonoprazan, 20mg, bid, Amoxicillin, 1.0 per dose, tid, orally, for 14 days.
Treatment group:Treatment with Vonoprazan-Amoxicillin high-dose dual therapy combined with Saccharomyces boulardii Vonoprazan 20 mg b.i.d. , Amoxicillin 1.0 g t.i.d. and Saccharomyces boulardii 500 mg

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years, regardless of gender; 2. Patients with current Helicobacter pylori infection (positive result in any one of the following tests: histopathological examination, rapid urease test, C13/C14 urea breath test, stool Helicobacter pylori antigen test); 3. No previous history of Helicobacter pylori eradication therapy; 4. Subjects who agree to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients complicated with severe gastric diseases such as gastric ulcer and gastric cancer, or patients with central venous catheterization; 2. Use of antifungal agents, H2 receptor antagonists (H2RAs), proton pump inhibitors (PPIs) and potassium-competitive acid blockers (P-CABs) within the past 2 weeks; use of bismuth agents, antibiotics (including traditional Chinese medicines with antibacterial effects) and probiotic preparations within the past 4 weeks; 3. Pregnant or lactating women; 4. Presence of other severe diseases that may interfere with the evaluation of this study, including severe hepatic, renal and cardiovascular diseases, malignant tumors and alcoholic intoxication; 5. Subjects with allergy to any study medication or a history of penicillin allergy; 6. Participation in other clinical trials within 3 months prior to enrollment; 7. Subjects unable to accurately describe their symptoms and personal willingness (e.g., psychosis, severe neurosis) and uncooperative with the trial.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori (Hp) eradication rate;

Secondary

MeasureTime frame
incidence rate of adverse events;treatment adherence;

Countries

China

Contacts

Public ContactWen Hongtao

The First Affiliated Hospital of Zhengzhou University

wenhongtao68@163.com+86 371 66271112

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026