Comparison of the effect of oral metronidazole and vaginal probiotics on the microbial flora of the vagina and evaluation of treatment failure in women with bacterial vaginosis

Phase 2

Recruiting

Conditions: Bacterial vaginosis.
Acute vaginitis
N76.0

Registration Number: IRCT20191104045328N10

Lead Sponsor: Arak University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 60

Inclusion Criteria

Women with a diagnosis of bacterial vaginosis
Age between 18 and 45 years
No pregnancy or HIV positive
No history of known medical conditions such as epilepsy, diabetes, hypertension and heart and gastrointestinal problems
Non-consumption of alcohol and anticoagulants such as coumadin (warfarin), immunosuppressants, vaginal medications, having an IUD

Exclusion Criteria

Dissatisfaction with continued cooperation
Having serious drug side effects
Do not take nutritional supplements
Existence of other non-bacterial infections of the vagina
Taking antibiotics

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amsel positive criteria. Timepoint: After the intervention. Method of measurement: Clinical examination and swabs biopsy of the vaginal wall.;Nugent score. Timepoint: After the intervention. Method of measurement: Gram stain scoring system for vaginal swabs.;The pH of vaginal discharge. Timepoint: Before and after the intervention. Method of measurement: PH meter tape with a range of 1/6 - 6/3 made by Machery – Nagel, Düren, Germany.;Existence of homogeneous dilute white-gray discharge. Timepoint: Before and after the intervention. Method of measurement: Clinical examination and swabs biopsy of the vaginal wall.;Amine test. Timepoint: Before and after the intervention. Method of measurement: Production of amine odor by adding 10% KOH solution to vaginal discharge.;The presence of Clue cells in the vaginal discharge slide. Timepoint: Before and after the intervention. Method of measurement: Preparation of microscopic slide sample from swap vaginal discharge.

Secondary Outcome Measures