Pregnant Women Who Test Positive for Bacterial VaginosisPhase 2ProVIPNCT01697683
Probiotic Therapy for the Reversal of Bacterial Vaginosis in Pregnancy
A Phase 2 study testing Probiotic Lactobacilli in people with Pregnant Women Who Test Positive for Bacterial Vaginosis, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women Who Test Positive for Bacterial Vaginosis
- What is being tested?
- Probiotic Lactobacilli
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant women prior to 17 weeks gestation
- singleton pregnancy
- over 18 years of age
- able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Probiotic Lactobacilli, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic LactobacilliDrug
Two capsules per day containing either probiotic lactobacilli or placebo for 12 weeks
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Rhamnosus Lactobacilli | Active comparator | Not described Receives: Drug: Probiotic Lactobacilli |
| Sugar pill | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial DNA profile
A change in the Vaginal Microbial DNA profile
Measured: At 28 and at 35 weeks gestation
Secondary outcomes (1)
Microbial function
A change in microbial function as measured by RNA transcriptomics
Measured: At 28 and at 35 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant Women Who Test Positive for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Sponsor
- Investigators
- Alan Bocking, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697683
- Sponsor's protocol ID
- 08-0005-A
- Acronym
- ProVIP
- Status last verified
- Mar 2014
- First submitted
- 28 Sep 2012
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Therapy for the Reversal of Bacterial Vaginosis in Pregnancy
- ClinicalTrials.gov ID
- NCT01697683
- Acronym / sponsor ID
- ProVIP / 08-0005-A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- May 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Rhamnosus Lactobacilli | Active comparator | Drug: Probiotic Lactobacilli |
| Sugar pill | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- pregnant women prior to 17 weeks gestation
- singleton pregnancy
- over 18 years of age
- able to provide informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic LactobacilliTwo capsules per day containing either probiotic lactobacilli or placebo for 12 weeks | Drug | Probiotic Rhamnosus Lactobacilli |
| Placebo | Drug | Sugar pill |
Primary outcome
Microbial DNA profile
Time frame: At 28 and at 35 weeks gestation
A change in the Vaginal Microbial DNA profile
1 secondary outcome
Microbial function
Time frame: At 28 and at 35 weeks gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Bocking, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic Lactobacilli in people with Pregnant Women Who Test Positive for Bacterial Vaginosis, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial DNA profile (time frame: At 28 and at 35 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014.