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IRCT20260519069453N1 IRCT 2026-05-20 Artesh University of Medical Sciences 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 2026-06-22 anticipated 88 Recruiting https://irct.ir/trial/90235 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method used is permuted block randomization. For this purpose, two treatment groups, A and B, are defined in blocks as AB and BA. Then, numbers from a random table in the range 0 to 9 are considered. Numbers 0 to 4 are assigned to block AB, and numbers 5 to 9 are assigned to block BA. Random numbers are then selected from the table. If the number 0 appears, it corresponds to block AB, and therefore two individuals enter this block, such that the first individual receives treatment A and the second individual receives treatment B. In the same way, the treatment groups for the remaining participants are determined. Although in this method the number of observations in both groups will be equal, because of the small block sizes, there is a high probability that the person conducting the study may predict the treatment group assignment. To solve this problem, the randomization list is prepared before the start of the study by a blinded individual who is not part of the treatment team. Additionally, the block sizes will be increased, Blinding description: Unwillingness to participate in the research project. This study is conducted in a double-blind manner; such that patients will be unaware of the type of intervention or their assigned group, and the assessor will also remain unaware of the patients’ allocation to study groups. In order to maintain blinding, the intervention in both groups is designed to be as similar as possible in terms of appearance, method of presentation, and implementation conditions, and the interventions are recorded with specific codes, and the information related to the codes is kept by an individual outside the assessment process until the end of data collection and analysis. 3 Benign prostatic hyperplasia. 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: Control group: Patients will receive Tamsulosin 0.4 mg once daily for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information available
public Parham Montazeri
Etemadzadeh St, Dr. Fatemi St., Shariati St.
Tehran Iran (Islamic Republic of) 1411718546 +98 21 8609 6353 parham18@gmail.com Artesh University of Medical Sciences scientific Farshad Namdari
Etemadzadeh St., Shariati St., Dr. Fatemi St.
Tehran Iran (Islamic Republic of) 1411718546 +98 21 8609 6356 Farshad.namd@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of benign prostatic hyperplasia based on clinical symptoms and confirmation by ultrasonography 40 years 75 years Male Unwillingness to participate in the research project N40.1 Enlarged prostate with lower urinary tract symptoms Treatment - Drugs Treatment - Drugs 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. Control group: Patients will receive Tamsulosin 0.4 mg once daily for 12 weeks. 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. 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. Artesh University of Medical Sciences Approved 2025-06-29 Ethics Committee of the Islamic Republic of Iran Army University of Medical Sciences Etemadzadeh St., Dr. Fatemi St., Shariati St. Tehran Tehran Iran (Islamic Republic of)