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

This study has been withdrawn prior to enrollment.
(Tightly defined inclusion criteria were making recruitment very slow.)
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Alan Bocking, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00217308
First received: September 14, 2005
Last updated: August 29, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention Phase
Premature Birth Bacterial Vaginosis Drug: Lactobacilli GR-1 and RC-14 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women at High Risk for Preterm Delivery

Resource links provided by NLM:


Further study details as provided by Alan Bocking, Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Determination if restoration of a normal vaginal flora through the use of probiotics reduces the incidence of PTB. [ Time Frame: 12 weeks ]

Enrollment: 0
Actual Study Start Date: February 2005
Study Completion Date: September 2007
Estimated Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217308

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Alan Bocking, MD, FRCSC Chief, Department of Obstetrics and Gynaecology, Mount Sinai Hospital
  More Information

Responsible Party: Alan Bocking, Clinician Scientist, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT00217308     History of Changes
Other Study ID Numbers: 04-0169-A
Study First Received: September 14, 2005
Last Updated: August 29, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Vaginosis, Bacterial
Premature Birth
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on September 21, 2017