Probiotic Therapy for the Reversal of Bacterial Vaginosis in Pregnancy (ProVIP)

This study has been completed.
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01697683
First received: September 28, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Pregnant Women Who Test Positive for Bacterial Vaginosis
Drug: Probiotic Lactobacilli
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Probiotic Therapy for the Reversal of Bacterial Vaginosis in Pregnancy

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Microbial DNA profile [ Time Frame: At 28 and at 35 weeks gestation ] [ Designated as safety issue: No ]
    A change in the Vaginal Microbial DNA profile


Secondary Outcome Measures:
  • Microbial function [ Time Frame: At 28 and at 35 weeks gestation ] [ Designated as safety issue: No ]
    A change in microbial function as measured by RNA transcriptomics


Enrollment: 86
Study Start Date: May 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Probiotic Rhamnosus Lactobacilli Drug: Probiotic Lactobacilli
Two capsules per day containing either probiotic lactobacilli or placebo for 12 weeks
Placebo Comparator: Sugar pill Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697683

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Alan Bocking, MD Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT01697683     History of Changes
Other Study ID Numbers: 08-0005-A
Study First Received: September 28, 2012
Last Updated: March 20, 2014
Health Authority: Canada: CIHR
Canada: Health Canada

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014