Effect of Probiotics on GBS Colonization Status During Pregnancy: A Pilot Randomized Controlled Trial

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ryerson University
• Collaborators: Chr Hansen; Chr Hansen A/S

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