Studying the effectiveness of probiotic Saccharomyces boulardii in patients resistant to treatment for Helicobacter pylori

Evaluation of the Effectiveness of Saccharomyces boulardii as an Adjunct Therapy in Treatment-Resistant Helicobacter pylori Patients: A Cohort Study in Ardabil

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251116068010N1

Enrollment

184

Registered

2025-11-21

Start date

2025-11-22

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Helicobacter pylori infection. Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere

Interventions

Intervention 1: Intervention group: Standard quadruple therapy plus Saccharomyces boulardii probiotic capsules. Intervention 2: Control group: Standard quadruple therapy plus placebo capsules.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Definitive diagnosis of H. pylori infection Failure of at least one standard triple or quadruple course of treatment Written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Immunodeficiency or use of immunosuppressive drugs History of probiotic use in the past month Known sensitivity to yeasts or components of the probiotic product

Design outcomes

Primary

Measure	Time frame
Eradication rate of Helicobacter pylori. Timepoint: At the beginning of the study (before the intervention) and the sixth week after the start of the administration. Method of measurement: Stool antigen test or UBT.;Severity of gastrointestinal symptoms. Timepoint: At the beginning of the study (before the intervention), and in the fourth and sixth weeks after the start of the administration. Method of measurement: GSRS questionnaire.;Incidence of treatment-related adverse events. Timepoint: The fourth and sixth weeks after the start of the administration. Method of measurement: GSRS questionnaire.;Quality of life. Timepoint: At the beginning of the study (before the intervention), and in the fourth and sixth weeks after the start of the administration. Method of measurement: SF-36 questionnaire.;Recurrence rate of H. pylori infection. Timepoint: Three months after the start of the administration. Method of measurement: Stool antigen test or UBT.	—

Measure

Time frame

Eradication rate of Helicobacter pylori. Timepoint: At the beginning of the study (before the intervention) and the sixth week after the start of the administration. Method of measurement: Stool antigen test or UBT.;Severity of gastrointestinal symptoms. Timepoint: At the beginning of the study (before the intervention), and in the fourth and sixth weeks after the start of the administration. Method of measurement: GSRS questionnaire.;Incidence of treatment-related adverse events. Timepoint: The fourth and sixth weeks after the start of the administration. Method of measurement: GSRS questionnaire.;Quality of life. Timepoint: At the beginning of the study (before the intervention), and in the fourth and sixth weeks after the start of the administration. Method of measurement: SF-36 questionnaire.;Recurrence rate of H. pylori infection. Timepoint: Three months after the start of the administration. Method of measurement: Stool antigen test or UBT.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactPourya Gholizadeh

Ardabil University of Medical Sciences

poorya.gholizadeh@gmail.com+98 45 3325 8763

Outcome results

None listed

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