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Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

NCT01558388 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-03-20

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    collaborator OTHER

  • Università degli Studi di Brescia

    lead OTHER

Principal Investigators

  • Luana Danti, MD · Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

  • Andrea Lojacono, MD · Università degli Studi di Brescia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01558388 on ClinicalTrials.gov