Overview

Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

Status:
Unknown status
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
Female
Summary
Bacterial vaginosis is a common vaginal condition involving a reduction in the amount of Lactobacilli, the normal bacteria colonizing the vagina, and an overgrowth of pathogenic bacteria. The presence of bacterial vaginosis in pregnancy is associated with an increased risk of preterm delivery. After a course of antibiotic treatment, recurrence of bacterial vaginosis has been reported in 10-70% of cases. This study aims to verify if administration of vaginal Lactobacilli may reduce the occurrence rate after antibiotic treatment of bacterial vaginosis during pregnancy.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Università degli Studi di Brescia
Collaborators:
Azienda Ospedaliera Spedali Civili di Brescia
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Criteria
Inclusion Criteria:

- singleton pregnancy

- gestational age 12-32 weeks

- diagnosis of bacterial vaginosis

- treatment of bacterial vaginosis with oral clindamycin 300 mg, twice-daily for 7 days

Exclusion Criteria:

- multiple pregnancy

- allergy to clindamycin