Evaluation of the efficacy of probiotics in the management of benign prostatic hyperplasia (BPH)

Clinical trial to evaluate the efficacy of probiotics as an adjunctive treatment in the management of benign prostatic hyperplasia (BPH) in patients attending the urology clinic of Imam Reza Hospital

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20260519069453N1

Enrollment

Registered

2026-05-20

Start date

2026-06-22

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Benign prostatic hyperplasia. Enlarged prostate with lower urinary tract symptoms

Interventions

Intervention 1: Intervention group: Patients will receive Tamsulosin 0.4 mg once daily and Gerilact probiotic tablets twice daily (morning and evening) for a period of 12 weeks. Intervention 2: Contro

Eligibility

Sex/Gender

Male

Age

40 Years to 75 Years

Inclusion criteria

Inclusion criteria: Definitive diagnosis of benign prostatic hyperplasia based on clinical symptoms and confirmation by ultrasonography

Exclusion criteria

Exclusion criteria: Unwillingness to participate in the research project

Design outcomes

Primary

Measure	Time frame
Severity of disease symptoms. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of drug administration. Method of measurement: Standard International Prostate Symptom Score questionnaire.	—

Secondary

Measure	Time frame
Residual urine volume. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of drug administration. Method of measurement: Ultrasonography.;Maximum urinary flow rate. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of drug administration. Method of measurement: Uroflowmetry.;Prostate volume. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of drug administration. Method of measurement: Ultrasonography.;Prostate-Specific Antigen. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of drug administration. Method of measurement: Blood test.	—

Measure

Time frame

Residual urine volume. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of drug administration. Method of measurement: Ultrasonography.;Maximum urinary flow rate. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of drug administration. Method of measurement: Uroflowmetry.;Prostate volume. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of drug administration. Method of measurement: Ultrasonography.;Prostate-Specific Antigen. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of drug administration. Method of measurement: Blood test.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParham Montazeri

Artesh University of Medical Sciences

parham18@gmail.com+98 21 8609 6353

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026