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The effect of Saccharomyces boulardii on the gut microbiota after the eradication of Helicobacter pylori with vonoprazan-amoxicillin dual therapy: a prospective, single center, randomized controlled trial

The effect of Saccharomyces boulardii on the gut microbiota after the eradication of Helicobacter pylori with vonoprazan-amoxicillin dual therapy: a prospective, single center, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075885
Enrollment
Unknown
Registered
2023-09-19
Start date
2023-10-18
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

Helicobacter pylori infection

Interventions

Probiotics combined with vonoprazan-amoxicillin dual therapy:Saccharomyces boulardii + vonoprazan + amoxicillin
vonoprazan-amoxicillin dual therapy:vonoprazan + amoxicillin

Sponsors

Affiliated Hospital of Yangzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients, aged 18-60 years old, regardless of gender; 2. Hp infected individuals diagnosed by 13C urea breath test (UBT) or 14C UBT; 3. Has not received standardized Hp eradication treatment in the past; 4. Volunteer to participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals who are allergic to the studied drugs (amoxicillin, vonoprazan); 2. Those who have used antibacterial drugs, bismuth agents, PPI, vonoprazan, or probiotics within the first month; 3. Patients who have failed to eradicate Hp in the past; 4. Have a history of acute gastroenteritis within the past month; 5. Patients with active peptic ulcer; 6. Patients with severe concomitant diseases, combined with acute upper gastrointestinal bleeding or malignant tumors; 7. Previous history of gastrointestinal surgery; 8. Being pregnant or breastfeeding; 9. Individuals who are addicted to alcohol, drugs, mental illness, or cognitive impairment and are unable to cooperate.

Design outcomes

Primary

MeasureTime frame
Changes in fecal gut microbiota before and after treatment;Changes in gastrointestinal symptoms before and after treatment;

Secondary

MeasureTime frame
The eradication rate of Helicobacter pylori;compliance;

Countries

China

Contacts

Public ContactDing Yanbing

Affiliated Hospital of Yangzhou University

ybding@yzu.edu.cn+86 137 7358 2299

Outcome results

None listed

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