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IRCT201206243706N13 IRCT 2012-07-14 Infectious disease research center Effectiveness of probiotics yoghurt on treatment and recurrence of bacterial vaginosis Effectiveness of probiotics yoghurt as a complementary method on treatment and recurrence of bacterial vaginosis: a randomized controlled trial 2012-07-22 anticipated 140 Complete https://irct.ir/trial/3805 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Bacterial Vaginosis. Intervention 1: Intervention group( metronidazol tablet + probiotic yogurt) at first 7 days metronidazol(500 mg Twice a day) then probiotic yogurtdaily for 2 month. Intervention 2: Control group( metronidazol tablet + Pasteurized yogurt)at first 7 days metronidazol(500 mg Twice a day) then Pasteurized yogurt daily for 2 month.
public Somayeh Ziyadi
Nursing & Midwifery faculty
Tabriz Iran (Islamic Republic of) 00 s.ziyadi@yahoo.com Nursing & Midwifery faculty scientific Dr.Sakineh Mohamad alizade Charandabi
Nursing & Midwifery faculty
Tabriz Iran (Islamic Republic of) 00 alizades@tbzmed.ac.ir Tabriz University of Medical Sciences, Nursing & Midwifery faculty Iran (Islamic Republic of) Inclusion criteria: 1- Married, non pregnant, non lactatating women aged 49-15 years 2-diagnosis of bacterial vaginosis by Amsel and Nugent Criteria). 3 - no abnormal vaginal bleeding. 4 - no probable intervening situations with the test results (menstruation at time of smear, having sex during last 48 houres, use of douch during last 48 houres) 5 -giving informeed consent to participate the study and be able to present at the clinic during next 24 houres, once every 2 weeks for next 2 month (to get the yoghurts), and also after 3 months, and after 6 months for assessments. Exclusion criteria: 1 - use of antibiotics in last 2 weeks. 2 - use of vaginal drugs in last 30 days. 3 - suffering from HIV. 4 - suffering from heart disease and kidney failure. 5 - Having surgery on the colon. 6 – smoking. 7 - Starting to use IUD in the last month or deciding to Insert IUD in following 3 months. 8 - useing immunosuppressive drugs. 15 years 49 years Female N76 other inflammation of vagina and vulva Treatment - Drugs Placebo Intervention group( metronidazol tablet + probiotic yogurt) at first 7 days metronidazol(500 mg Twice a day) then probiotic yogurtdaily for 2 month. Control group( metronidazol tablet + Pasteurized yogurt)at first 7 days metronidazol(500 mg Twice a day) then Pasteurized yogurt daily for 2 month. Microbiological cure. Timepoint: 10+-2 days after starting treatment. Method of measurement: Microbiologocal cure as assessed by Amsel criteria and Nugent score. Recurrence of bacterial vaginosis. Timepoint: 90 and 180 +- 7 days after starting treatment. Method of measurement: Amsel criteria and Nugent score. Clinical cure. Timepoint: 10 +- 3 days and 90 and 180 +-7 days after starting treatment. Method of measurement: Patient and clinician reports. Infectious disease research center Approved 2012-07-02 Tabriz University of Medical Sciences, Reaserch deputy Golgasht Tabriz Iran (Islamic Republic of)