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IRCT20100102002954N18 IRCT 2020-01-09 Shahroud University of Medical Sciences Evaluation of the effect of probiotics on urinary tract infection in the elderly Evaluation of the effect of probiotics on urinary tract infection in the elderly admitted in infection ward of Imam Hossain hospital of Shahroud a randomized clinical trial. 2020-01-20 anticipated 64 Complete https://irct.ir/trial/44751 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The patients enrolled in the study are divided into intervention and control groups. Patients in the intervention group will receive 250 ml of probiotic yoghurt twice daily (14 days) in addition to receiving routine treatment including appropriate serum and appropriate antibiotics. Patients in the control group will receive 250 ml of standard yoghurt twice daily (14 days) as the intervention group in addition to routine treatment including appropriate serum and antibiotics, Randomization description: Randomization was done using permuted block randomization method using blocked random allocation syntax in SPSS software. For calculation sample size, number of blocks and block size was determined. Block size was 4. Allocation concealment was done using closed opaque envelope, Blinding description: In this study, patients; clinical caregiver,outcome evaluator and analyzer it are blinded. The division of patients into two groups A and B is done by a qualified nurse who has no knowledge of the actions performed in the two groups. Do clinical examination of patients and results recorder will be done by a qualified nurse without any knowledge of the type of intervention and patients group. N/A Urinary Tract Infection. Intervention 1: Intervention group: Patients in the intervention group will receive 250 ml of probiotic yoghurt twice daily for 14 days in addition to receiving routine therapy including appropriate serum and antibiotics. Intervention 2: Control group: Patients in the control group will receive 250 ml of standard yoghurt twice daily for 14 days in addition to receiving routine therapy including appropriate serum and antibiotics. 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 Once the plan is completed and consulted with colleagues, decisions will be made.
public Dr. Fatemeh Ghabel
Imam Hossein Hospital., End Imam street.,
Shahroud Iran (Islamic Republic of) 3616611151 +98 23 3234 2000 fate.qbl@gmail.com Shahroud University of Medical Sciences scientific Dr. Ehsan Nezakati
Imam Hossein Hospital., End Imam street.,
Shahroud Iran (Islamic Republic of) 3616611151 +98 23 3234 2000 drenezakati@shmu.ac.ir Shahroud University of Medical Sciences Iran (Islamic Republic of) Patients with at least 60 years of age, Patients with a urinary tract infection proven by E. coli, Having the consent to participate in the project. 60 years no limit Both Any kind of autoimmune disease, Unstable clinical condition, Taking antibiotics in the last week, Kidney failure, Any obstructive factor in the path of the urinary tract system, Diabetes, The existence of a transplanted kidney, Need for surgery. N39.0 Urinary tract infection, site not specified Treatment - Other Treatment - Other Intervention group: Patients in the intervention group will receive 250 ml of probiotic yoghurt twice daily for 14 days in addition to receiving routine therapy including appropriate serum and antibiotics. Control group: Patients in the control group will receive 250 ml of standard yoghurt twice daily for 14 days in addition to receiving routine therapy including appropriate serum and antibiotics. Decrease in clinical symptoms of urinary tract infection including: fever, dysuria, recurrence and urgency. Timepoint: Daily. Method of measurement: Patient examination and patient interview. Reduce the number of bacteria in urine analysis. Timepoint: Two daily. Method of measurement: Standard urinalysis test. Negative urine culture. Timepoint: Weekly. Method of measurement: Standard urine culture test. Recurrence of urinary tract infection. Timepoint: Monthly for three months. Method of measurement: Standard urine culture test. Vice chancellor for research; Shahroud University medical and Sciences Approved 2018-07-22 Shahroud University of Medical Sciences Shahroud University of Medical Sciences; 7 Tir squer, Shahroud Shahroud Semnan Iran (Islamic Republic of)