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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00217308
• Other study ID #: 04-0169-A
• Status: Withdrawn
• Phase: Phase 1
• First received: September 14, 2005
• Last updated: August 29, 2017
• Start date: February 2005
• Est. completion date: September 2007

Study information

• Verified date: August 2017
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Premature Birth
• Vaginosis, Bacterial

Intervention

Drug:
• Lactobacilli GR-1 and RC-14
Probiotic Lactobacilli will be compared to placebo

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination if restoration of a normal vaginal flora through the use of probiotics reduces the incidence of PTB.		12 weeks