Probiotics for Group B Strep Carrier in Pregnancy
(OPSiP Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byPatricia Janssen, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of British Columbia

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a double-blind randomized placebo controlled trial that will investigate whether the use of three specific species of probiotics taken orally in pregnancy from 25 weeks gestation will reduce the incidence of Group B Streptococcus (GBS) colonization. Participants will take 2 capsules and 1 lozenge per day of either probiotic or placebo from 25 weeks gestation. The primary outcome will be the study-specific vaginal/rectal swab collected after 35 weeks gestation and before delivery. A reduction in women testing positive for GBS would lead to a decrease risk to infants of GBS infection and a reduction in the use of antibiotics leading to less maternal and neonatal antibiotic exposure.

Eligibility Criteria

This trial is for pregnant women over 18, with a single baby and less than 25 weeks along. They must be under the care of a maternity provider and planning to deliver at a participating center. Women with significant immunosuppression, prior GBS-affected infants, or certain health conditions like diabetes are excluded.

Inclusion Criteria

Pregnant with a singleton

Gestational age between 23 and 25+0 weeks

Under the care of a regulated maternity care provider (midwife, obstetrician (OB), or family physician)

+2 more

Exclusion Criteria

GBS bacteriuria diagnosed in present pregnancy (reasoning as per above)

I plan to use probiotic supplements during my pregnancy.

I have Type I or Type II diabetes.

+5 more

Participant Groups

The study tests if taking specific probiotics orally from week 25 of pregnancy reduces Group B Streptococcus colonization compared to a placebo. Participants will take capsules and lozenges daily until they give birth, aiming to lower infant infection risk and antibiotic use.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment1 Intervention

Probiotic supplementation

Group II: ControlPlacebo Group1 Intervention

Placebo