Effect of Probiotics on GBS Colonization Status During Pregnancy: A Pilot Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT02528981|
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : March 7, 2017
Group B Streptococcus (GBS) is the leading cause of neonatal morbidity and mortality in Canada. It may be passed from a study participant colonized in the genital tract by GBS to their baby during vaginal birth. While approximately 10 to 30% of pregnant people harbour GBS in the vagina or rectum, the incidence of neonatal GBS disease is 1 to 2 infants per 1000 births. The use of intrapartum antibiotics to treat colonized individuals with or without risk factors has led to a 70% decline in the incidence of early-onset GBS sepsis in the past decade. Despite this impressive decline, antibiotic resistance has become a major public health concern. Association between intrapartum antibiotic use and ampicillin resistance in E. coli isolated from neonates has previously been documented. Furthermore, while GBS has remained sensitive to penicillin, 20% are resistant to erythromycin and clindamycin, which are alternate drugs for patients allergic to penicillin. Alternative approaches are therefore needed to reduce the risk of GBS infection.
We therefore propose to study the use of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 (Lactobacillus fermentum RC-14) in the colonization status of GBS in pregnant people. Lactobacilli are part of normal gut and vaginal flora and have been widely used as probiotics to treat various conditions. In particular, these two strains have shown to be beneficial in the treatment of urinary tract infections and bacterial vaginosis. Our study design involves recruiting two hundred pregnant people (one hundred in each arm) through various midwifery practices in the GTA at the end of their first trimester of pregnancy. These individuals will be randomized to receive probiotics or placebo for twelve weeks of their pregnancies and will be cultured before delivery to determine their colonization status. The capsules with probiotics and placebo will be provided free of charge. The study design was chosen to minimize the cost and clients' visits to the clinic as vaginal/rectal swabs are routinely offered at 35-37 weeks of gestation.
|Condition or disease||Intervention/treatment||Phase|
|Group B Streptococcal Infection||Drug: Probiotic Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Probiotics on GBS Colonization Status During Pregnancy: A Pilot Randomized Controlled Trial|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||July 2016|
L. rhamnosus GR-1 and L. reuteri RC-14 will be supplied to 100 randomized pregnant people in gelatin capsules containing 2.5 billion viable cells of each strain (CFU). These organisms have been previously shown to colonize the vagina after being taken orally (11) and displace the pathogens causing bacterial vaginosis (12) and vaginal yeast infections (13), and have been shown to be an effective treatment, or accessory to treatment of these conditions. (7- 9, 13)
Lactobacillus GR-1 and RC-14
Placebo Comparator: Placebo
Placebo capsules will be supplied to 100 randomized pregnant people in gelatin capsules that are identical to the probiotics that the experimental group will receive.
- The GBS colonization status of people as determined by a vaginal/rectal swab [ Time Frame: After 12 weeks of taking capsules ]The primary outcome of this study is the GBS colonization status of people as determined by a vaginal/rectal swab, routine to the standard course of midwifery care, taken at 35-37 weeks of pregnancy. Thus, clients are asked to participate in the study for approximately 12 weeks, as per the course of probiotic/placebo. Clients will stop taking the capsules after 12 weeks and once the swab has been performed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528981
|Toronto, Ontario, Canada|
|Principal Investigator:||Mary Sharpe, PhD||Ryerson University|