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

NCT00217308 | Withdrawn Phase 1

• 1 other identifier: 04-0169-A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Birth; Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• Determination if restoration of a normal vaginal flora through the use of probiotics reduces the incidence of PTB.

  12 weeks

Study Arms (2)

Lactobacillus

EXPERIMENTAL

Drug: Lactobacilli GR-1 and RC-14

Placebo capsules

PLACEBO COMPARATOR

Drug: Lactobacilli GR-1 and RC-14

Interventions

Lactobacilli GR-1 and RC-14 DRUG

Probiotic Lactobacilli will be compared to placebo

Lactobacillus; Placebo capsules

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Premature Birth; Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases

Study Officials

• Alan Bocking, MD, FRCSC

  Chief, Department of Obstetrics and Gynaecology, Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: February 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: September 1, 2007
• Last Updated: August 31, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)