Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy
- Registration Number
- NCT01558388
- Lead Sponsor
- Università degli Studi di Brescia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Vaginal lactobacilli Lactobacillus acidophilus -
- Primary Outcome Measures
Name Time Method Vaginal lactobacillus recolonization 3-5 weeks Recurrence rate of bacterial vaginosis 3-5 weeks
- Secondary Outcome Measures
Name Time Method Preterm delivery <37 weeks within 43 weeks of gestation
Trial Locations
- Locations (1)
Ostetricia 1, Azienda Ospedaliera Spedali Civili di Brescia
🇮🇹Brescia, Italy