NCT01558388

Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

Randomised Control Trial of Probiotics Versus Placebo as Adjuvant to Oral Clindamycin Treatment for Bacterial Vaginosis During Pregnancy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Università degli Studi di Brescia · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	Lactobacillus acidophilus	Lactobacillus acidophilus 500 million colony-forming units/tablets. One vaginal tablet daily for 10 days.
DRUG	Placebo	One vaginal tablet daily for 10 days.

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-03-20
• Last updated: 2012-03-20

Locations

1 site across 1 country: Italy