Skip to content

A Multicenter, Randomized, Controlled Study Evaluating the Efficacy and Safety of Saccharomyces boulardii Sachets in Combination with Vonoprazan-Amoxicillin Dual Therapy for the Treatment of Helicobacter pylori-Positive Chronic Gastritis

A Multicenter, Randomized, Controlled Study Evaluating the Efficacy and Safety of Saccharomyces boulardii Sachets in Combination with Vonoprazan-Amoxicillin Dual Therapy for the Treatment of Helicobacter pylori-Positive Chronic Gastritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112879
Enrollment
Unknown
Registered
2025-11-20
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

HP-positive chronic gastritis

Interventions

Investigational Group:Triple therapy
Control group:Dual therapy

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Age >= 18 years, regardless of gender. Meet the diagnostic criteria for chronic gastritis, with reference to the Chinese Guidelines for the Diagnosis and Management of Chronic Gastritis (2022). Positive result on the ¹³C or ¹4C urea breath test. Patients who are either receiving anti-Helicobacter pylori therapy for the first time or have a history of failed prior anti-H. pylori treatment. Signed informed consent form.

Exclusion criteria

Exclusion criteria: Individuals with a known or suspected allergy to the investigational product or any of its components. Participation in another clinical trial within the past month. Patients with a central venous catheter for intravenous infusion. Patients with fructose and lactose intolerance. Patients who are immunocompromised or hospitalized due to a critical illness or impaired immune system. Any other condition that, in the investigator's judgment, may pose a risk to the patient.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate;

Secondary

MeasureTime frame
Incidence and severity of adverse reactions;

Countries

China

Contacts

Public ContactTanzhou Chen

The First Affiliated Hospital of Wenzhou Medical University

cctzz@163.com+86 577 8668 9192

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026