Probiotic Therapy for the Reversal of Bacterial Vaginosis in Pregnancy (ProVIP)
Primary Purpose
Pregnant Women Who Test Positive for Bacterial Vaginosis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Probiotic Lactobacilli
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pregnant Women Who Test Positive for Bacterial Vaginosis
Eligibility 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
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probiotic Rhamnosus Lactobacilli
Sugar pill
Arm Description
Outcomes
Primary Outcome Measures
Microbial DNA profile
A change in the Vaginal Microbial DNA profile
Secondary Outcome Measures
Microbial function
A change in microbial function as measured by RNA transcriptomics
Full Information
NCT ID
NCT01697683
First Posted
September 28, 2012
Last Updated
March 20, 2014
Sponsor
Mount Sinai Hospital, Canada
Collaborators
Unity Health Toronto
1. Study Identification
Unique Protocol Identification Number
NCT01697683
Brief Title
Probiotic Therapy for the Reversal of Bacterial Vaginosis in Pregnancy
Acronym
ProVIP
Official Title
Probiotic Therapy for the Reversal of Bacterial Vaginosis in Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada
Collaborators
Unity Health Toronto
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnant Women Who Test Positive for Bacterial Vaginosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic Rhamnosus Lactobacilli
Arm Type
Active Comparator
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Probiotic Lactobacilli
Intervention Description
Two capsules per day containing either probiotic lactobacilli or placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Microbial DNA profile
Description
A change in the Vaginal Microbial DNA profile
Time Frame
At 28 and at 35 weeks gestation
Secondary Outcome Measure Information:
Title
Microbial function
Description
A change in microbial function as measured by RNA transcriptomics
Time Frame
At 28 and at 35 weeks gestation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Bocking, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Probiotic Therapy for the Reversal of Bacterial Vaginosis in Pregnancy
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