Effect of Probiotics on GBS Colonization Status During Pregnancy: A Pilot Randomized Controlled Trial
Group B Streptococcal Infection
About this trial
This is an interventional prevention trial for Group B Streptococcal Infection focused on measuring GBS, Probiotics, Group B Streptococcal, Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant prior to 23 weeks' gestation
- Singleton pregnancy
- Greater than 18 years of age
- Lesser than 45 years of age
- Signed Informed Consent
- Consent to GBS swab that will be offered at the 35-37 week visit
- Consent to chart review at study conclusion
Exclusion Criteria:
- Multifetal pregnancy
- Fetal complications
- History of preterm birth/second trimester loss
- Significant maternal medical complications
- Unable to provide informed consent
- 18 years of age or lesser than 18 years of age
- 45 years of age or greater than 45 years of age
- HIV positive
- Immuno-compromised E.g.: Persons with AIDS; cancer and transplant patients who are taking certain immunosuppressive drugs; and those with inherited diseases that affect the immune system (e.g., congenital agammaglobulinemia, congenital IgA deficiency).
- History of previous child affected by Early Onset GBS Disease (EOGBSD)
- GBS bacteruria in pregnancy
- Antibiotic treatment required during study period
- Enrolled in other research with a drug
- Taking another probiotic supplement
Sites / Locations
- Ryerson University
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Probiotic
Placebo
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)
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.