Effect of Probiotics on GBS Colonization Status During Pregnancy: A Pilot Randomized Controlled Trial
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
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.