168 Participants Needed

Probiotics for Group B Strep Carrier in Pregnancy

(OPSiP Trial)

Recruiting at 1 trial location
KH
EC
Overseen ByErin Cooke
Age: 18 - 65
Sex: Female
Trial Phase: Phase 3
Sponsor: University of British Columbia
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

MM

Michelle M Butler, PhD, RM

Principal Investigator

Dublin City University

PJ

Patricia Janssen, PhD

Principal Investigator

UBC School of Population and Public Health

Are You a Good Fit for This Trial?

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)
See 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.
See 5 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

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+
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