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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191104045328N10

Enrollment

Registered

2022-05-10

Start date

2022-05-22

Completion date

Unknown

Last updated

2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial vaginosis. Acute vaginitis

Interventions

Intervention 1: Metronidazole group: Oral treatment with 500 mg metronidazole twice daily for 7 days. Intervention 2: Probiotic group: Probiotic vaginal capsules (lactobacillus acidophilus, lactobacil

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Nazila Najdi

Arak University of Medical Sciences

najdinazila@gmail.com+98 86 3222 2003

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026