Probiotic Therapy for the Reversal of Bacterial Vaginosis in Pregnancy

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will add to the current knowledge and literature on the ability of an oral lactobacilli preparation to return the vaginal flora to a normal state in pregnant women. The results will potentially serve as the basis for a multi-centre Phase III randomized clinical trial to determine the efficacy of this treatment in preventing preterm birth.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mount Sinai Hospital, Canada
• Collaborators: St. Michael's Hospital, Toronto; Unity Health Toronto

Criteria

Inclusion Criteria:

• pregnant women prior to 17 weeks gestation

• singleton pregnancy

• over 18 years of age

• able to provide informed consent

Exclusion Criteria:

• multifetal pregnancies (twins, triplets, etc)

• fetal complications (congenital anomaly, chromosomal abnormality)

• maternal history of previous preterm birth or second trimester loss

• significant maternal medical or surgical complications (eg. hypertension, diabetes)

• less than 18 years of age

• unable to provide informed consent

• HIV Positive

• Immuno-compromised