Effect of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women at High Risk for Preterm Delivery

Purpose of the study is to determine the effect of probiotic lactobacilli on the vaginal flora and cytokine profile during pregnancy, and the incidence of preterm labour in women at high risk for preterm birth.

Study Overview

• Status: Withdrawn
• Conditions: Premature Birth; Bacterial Vaginosis
• Intervention / Treatment: Drug: Lactobacilli GR-1 and RC-14

Detailed Description

Preterm labour involves multiple causes - one of the most significant factors being a prior history of preterm birth. Infection is another major cause of preterm labour (PTL) and is estimated to cause up to 30% of PTL. Bacterial Vaginosis (BV) is an alteration in the endogenous vaginal microflora preceded by a decreased presence of Lactobacilli species and increased growth of gardnerella and other pathogens. BV is a strong risk factor for PTL, and is associated with a 40% increased risk in some populations. Initial studies suggested that the treatment of BV with antibiotics could decrease the incidence of PTL, but this has not been confirmed by randomized trials. There is substantial evidence that the "normal" lactobacillus dominated urogenital microflora play an important role in maintenance of a healthy urinary and reproductive tract.

One hundred and sixty (160) women at high risk for PTL, based on a prior history of preterm birth, will be approached at their first antenatal visit to participate. Recruitment of 54 patients with symptomatic or asymptomatic BV (based on Nugent Scoring). Women with documented BV will be randomized to either treatment with lactobacilli preparation (n=27) or placebo (n=27). Women with symptomatic BV will be treated with oral Metronidazole prior to starting the lactobacilli or placebo. None of the subjects, researchers or clinical staff will know which preparation each woman receives.

This study will be the first to examine the ability of lactobacilli preparations to maintain a normal vaginal flora in pregnant women. In addition, the results will potentially serve as the basis for a multi-centre RCT to determine efficacy of this treatment in preventing preterm birth.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• pregnant women with previous incidence of preterm labour
• otherwise healthy
• over 18 years of age
• able to provide informed consent
• less than or equal to 16 weeks gestation
• singleton pregnancy
• normal uterine cavity

Exclusion Criteria:

• significant medical complications (preeclampsia, thrombophilia, hypertension)
• multiple pregnancy
• less than 18 years of age
• patients receiving antibiotics or other antimicrobial therapies at time of recruitment
• fetal complications such as intrauterine growth restriction or other abnormalities
• diabetes
• documented need for cervical cerclage
• patient enrolled in other clinical trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactobacillus	Drug: Lactobacilli GR-1 and RC-14; Probiotic Lactobacilli will be compared to placebo
Placebo Comparator: Placebo capsules	Drug: Lactobacilli GR-1 and RC-14; Probiotic Lactobacilli will be compared to placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determination if restoration of a normal vaginal flora through the use of probiotics reduces the incidence of PTB.	12 weeks

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Alan Bocking, MD, FRCSC, Chief, Department of Obstetrics and Gynaecology, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2005
• Primary Completion (Anticipated): July 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: September 14, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Actual): August 31, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Vaginal Diseases; Vaginitis; Premature Birth; Vaginosis, Bacterial
• Other Study ID Numbers: 04-0169-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No