Comparing the Efficacy of Probiotic and Antibiotic Combination Therapy with Antibiotic Therapy Alone on the Recurrence of Bacterial Vaginosis

Phase 2

Conditions: Bacterial vaginosis.
Acute vaginitis
N76.0

Registration Number: IRCT20230814059147N1

Lead Sponsor: DME of Nishtar hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 120

Inclusion Criteria

Women 18–45 years old
Having bacterial vaginosis diagnosed according to Amsel's criteria (at least three of the following BV symptoms: Greyish white, thin, homogenous vaginal discharge, vaginal pH >4.5, positive amine test findings, and presence of clue cells (>20%) in a wet smear observed under microscopy)
all cured with metronidazole

Exclusion Criteria

History of allergy against the study drug.
Pregnant
Lactating women
Menopausal women
History of bleeding from the genital tract of unknown etiology
Women with malignancy of reproductive tract or any co-morbid condition like AIDS, diabetes, psychiatric illness
Currently using any contraceptive method
Patients using another oral or vaginal probiotic at the time of assessment or receiving antibiotic therapy for another reason

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of Bacterial Vagniosis. Timepoint: at 3 month. Method of measurement: Using Amsel Criteria (at least three of the following BV symptoms: Greyish white, thin, homogenous vaginal discharge, vaginal pH >4.5, positive amine test findings, and presence of clue cells (>20%) in a wet smear observed under microscopy).

Secondary Outcome Measures