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Effectiveness of probiotics yoghurt on treatment and recurrence of bacterial vaginosis

Not Applicable
Conditions
Bacterial Vaginosis.
other inflammation of vagina and vulva
Registration Number
IRCT201206243706N13
Lead Sponsor
Infectious disease research center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
140
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.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.
Secondary Outcome Measures
NameTimeMethod
Clinical cure. Timepoint: 10 +- 3 days and 90 and 180 +-7 days after starting treatment. Method of measurement: Patient and clinician reports.
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