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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230814059147N1
Enrollment
120
Registered
2024-01-10
Start date
2022-04-01
Completion date
Unknown
Last updated
2024-01-22

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: Intervention group: antibiotics and probiotics combined: In Group A, probiotics (Lactobacillus plantarum PBS067, Lactobacillus rhamnosus LRH020, and Bifidobacterium animalis lactis BL0

Sponsors

DME of Nishtar hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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).

Countries

Pakistan

Contacts

Public ContactDr. Saima Ashraf

Nishtar Hospital, Multan

saimashahzad35177@gmail.com+92 311 8443876

Outcome results

None listed

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