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Study on the efficacy of Saccharomyces boulardii in preventing and controlling adverse reactions during high-dose dual therapy for Helicobacter pylori eradication

Study on the efficacy of Saccharomyces boulardii in preventing and controlling adverse reactions during high-dose dual therapy for Helicobacter pylori eradication

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123827
Enrollment
Unknown
Registered
2026-04-30
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Helicobacter pylori infection

Interventions

Intervention group:Vonoprazan and amoxicillin dual eradication regimen combined with Saccharomyces boulardii
Control group:Vonoprazan and amoxicillin dual eradication regimen

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 70 years old; 2.Treatment-naive patients with Helicobacter pylori infection confirmed by ¹³C urea breath test; 3.Alert and conscious with full capacity for independent behavior, capable of cooperating with the intervention; 4.Voluntarily agree to participate in this study and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1.Previous history of Helicobacter pylori eradication therapy; 2.Known allergy to any study medication, or presence of contraindications to eradication therapy; 3.Pregnant or breastfeeding women; 4.Recent use of medications that may affect the gut microbiota, such as antibiotics, probiotics, acid-suppressive drugs, etc; 5.Previous history of gastrointestinal surgery; 6.Severe comorbidities: serious diseases of the heart, lung, liver, kidney or other vital organs, or other conditions that may affect the study results; 7.Alcohol abusers or drug addicts; 8.Diseases affecting the primary outcome: diarrhea, constipation, abdominal pain, nausea, rash, peptic ulcer, inflammatory bowel disease, celiac disease, etc.

Design outcomes

Primary

MeasureTime frame
Gastrointestinal Symptom Rating Scale (GSRS) Score;Incidence of adverse reactions;

Secondary

MeasureTime frame
Sleep Quality;Depressive tendency;Nutritional status;Helicobacter pylori eradication rate;

Countries

China

Contacts

Public ContactMa Yongchen

Peking University First Hospital

yongchenma@bjmu.edu.cn+86 15501117699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026