Probiotic Therapy for the Reversal of Bacterial Vaginosis in Pregnancy
Condition: Pregnant Women Who Test Positive for Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Preterm birth continues to provide the greatest challenge in perinatal health care in the
      developed world. It is a syndrome involving multiple causes and arises from a number of
      social, psychological, and biological determinants. It has been estimated that intrauterine
      infection accounts for at least 25-40% of spontaneous preterm births, with infection being
      the primary cause of extreme prematurity. Because infection-mediated preterm delivery mainly
      occurs in younger gestational ages (less than 28 weeks), these extremely premature babies not
      only have the risks associated with being born early, but are also likely to have severe
      morbidities associated with infection. Bacterial vaginosis (BV) is defined as a loss or
      significant depletion of lactobacilli coupled with an overgrowth of pathogenic bacteria and
      an increase in vaginal pH (>4.5). BV is common and occurs in 20% of the general female
      population, often without symptoms and is associated with a 40% increased risk of preterm
      birth. The clinical finding that lactobacilli is the dominant microbe in the vagina of women
      with a healthy pregnancy and full term delivery, supports the association of this species
      with a healthy pregnancy. BV is associated with an elevation of cervico-vaginal
      pro-inflammatory cytokines including IL-1β and IL-8 that are also associated with preterm
      labour; initiating the inflammatory cascade of events involved in labour may be the mechanism
      by which BV triggers preterm birth. However, not all women with BV will deliver preterm
      suggesting that variations in genetic susceptibility may underlie the host response to the
      presence of BV and the risk for preterm birth. Antibiotic therapy is the current treatment
      for BV, but the extent to which antibiotics can prevent preterm birth in women with BV
      remains somewhat uncertain, with conflicting results published in the literature. The
      apparent ineffective nature of antibiotic therapy, perhaps due to a lack of regrowth of
      lactobacilli following treatment, and the possibility that the pathogens have already induced
      inflammatory processes that will eventually induce preterm birth, emphasizes the need to
      continue to investigate the role of microbes during pregnancy. Probiotics have been suggested
      as an alternative to antibiotic therapy in restoring vaginal lactobacilli and reversing BV.
      The study seeks to determine whether Lactobacillus rhamnosus, GR-1 and Lactobacillus reuteri,
      RC-14 when administered to pregnant women diagnosed with bacterial vaginosis or intermediate
      flora will reverse the condition leading to a decrease in the inflammatory mediators involved
      in the cascade of infection/inflammation-mediated preterm birth.
    

Intervention name(s): Probiotic Lactobacilli; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two capsules per day containing either probiotic lactobacilli or placebo for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment