Bacterial Vaginosis
Conditions
Brief 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.
Interventions
Lactobacillus acidophilus 500 million colony-forming units/tablets. One vaginal tablet daily for 10 days.
DRUGPlacebo
One vaginal tablet daily for 10 days.
Sponsors
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Università degli Studi di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaginal lactobacillus recolonization | 3-5 weeks |
| Recurrence rate of bacterial vaginosis | 3-5 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Preterm delivery <37 weeks | within 43 weeks of gestation |
Countries
Italy
Outcome results
None listed