NCT01697683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 24, 2014

Status Verified

March 1, 2014

Enrollment Period

1.8 years

First QC Date

September 28, 2012

Last Update Submit

March 20, 2014

Conditions

Pregnant Women Who Test Positive for Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

  • Microbial DNA profile

    A change in the Vaginal Microbial DNA profile

    At 28 and at 35 weeks gestation

Secondary Outcomes (1)

  • Microbial function

    At 28 and at 35 weeks gestation

Study Arms (2)

Probiotic Rhamnosus Lactobacilli

ACTIVE COMPARATOR
Drug: Probiotic Lactobacilli

Sugar pill

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Probiotic LactobacilliDRUG

Two capsules per day containing either probiotic lactobacilli or placebo for 12 weeks

Probiotic Rhamnosus Lactobacilli
PlaceboDRUG
Sugar pill

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women prior to 17 weeks gestation
  • singleton pregnancy
  • over 18 years of age
  • able to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Study Officials

  • Alan Bocking, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2012

First Posted

October 2, 2012

Study Start

May 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 24, 2014

Record last verified: 2014-03

Locations

CA(1)