Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

Università degli Studi di Brescia

Status and phase: Unknown; Phase 4

Conditions: Bacterial Vaginosis

Treatments: Drug: Placebo; Drug: Lactobacillus acidophilus

Study type: Interventional

Funder types: Other

Identifiers

NCT01558388

Spedali Civili 926

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Vaginal lactobacilli

Experimental group

Treatment:

Drug: Lactobacillus acidophilus

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo