Probiotics for Group B Strep Carrier in Pregnancy

(OPSiP Trial)

Recruiting at 1 trial location

Overseen By Erin Cooke

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: University of British Columbia

Disqualifiers: Immunosuppression, Diabetes, GBS history, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: Approximately 15 weeks

168 Participants Needed

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.

Research Team

Michelle M Butler, PhD, RM

Principal Investigator

Dublin City University

Patricia Janssen, PhD

Principal Investigator

UBC School of Population and Public Health

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)

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive daily oral supplementation of probiotics or placebo from 25 weeks gestation until delivery

Approximately 15 weeks

3 visits (in-person) for swab collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks postpartum

Chart review and questionnaires

Treatment Details

Interventions

• Placebo
• Probiotic supplementation

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Probiotic supplementation

Group II: Control Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Dublin City University

Collaborator

Trials

20

Recruited

10,900+